louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02508272: Transcriptomic Profiling in Severely Injured Patients
Official title: Transcriptomic Profiling in Severely Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Inflammation
Sepsis
Keywords: Transcriptome profiling
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 115
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: Trauma patients with systemic inflammation due to multiple injuries (Polytrauma: ISS ≥ 17 points)

Brief summary: Discovery of differences in the host response in patients with systemic inflammation and sepsis, and identification of novel, specific markers by using a longitudinal clinico-transcriptomic approach.

Detailed description: The aim of this study is to link defined clinical phenotypes with data on RNA obtained from blood samples by high throughput technologies. Genetic and molecular characteristics of the immune system after severe trauma will be crosslinked to clinical aspects of posttraumatic organ failure, with the goal of identifying typical molecular "fingerprints". Patients with and without sepsis or organ failure will be compared with the goal to develop a diagnostic test designed to predict the clinical course following severe trauma. Criteria for study enrollment includes patient age ≥18 y, an Injury Severity Score (ISS) ≥ 17 points, and time from injury to admission \< 6 h. Whole blood from trauma patients will be collected within the first 6 h after trauma (day 0) and on days 1, 2, 3, 5, 7, 10, 14, and 21.

Eligibility criteria: Inclusion Criteria:

* patient age ≥18 y
* Injury Severity Score (ISS) ≥ 17 points
* time from injury to admission \< 6 h.

Exclusion Criteria:

Moribund Patients with:

* PH \< 7,1 or
* Lactate \> 15 mmol/l or
* Base deficit \> 15 mEq/l

Primary outcomes:
measure: Systemic Inflammation and Sepsis
timeFrame: 21 days after trauma
Secondary outcomes:
measure: Mortality
timeFrame: 28 days after Trauma
measure: Nosocomial infections
timeFrame: 21 days after trauma
measure: SOFA score
timeFrame: 21 days after trauma
measure: Systemic inflammation score
timeFrame: 21 days after trauma
measure: Hospital length of stay
timeFrame: 28 days after trauma
measure: ICU length of stay
timeFrame: 28 days after trauma
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Trauma Surgery
Study officials:
affiliation: University of Zurich
name: Guido A Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434872: Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Microbiota
Ulcerative Colitis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).

FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.

Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.

At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.

Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.


Eligibility criteria: Inclusion Criteria:

* Over 3 month diagnosis of ulcerative colitis
* Active Colitis disease with endoscopic score \>0
* Ability to sign an informed consent

Exclusion Criteria:

* Acute neutrophilia (under 500 neutrophils)
* Clostridium difficile infection
* Exposure to antibiotics 2 weeks prior to enrollment.
* Severe immune deficiency
* Hospitalization
* Proctitis involving less than 10cm of the rectum
* Malignancy with the past 5 years (excluding BCC)
* An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks

Primary outcomes:
measure: Clinical improvement
timeFrame: 8 weeks after FMT
Secondary outcomes:
measure: Histological remission assessed by sigmoidoscopy
timeFrame: 8 weeks after FMT
measure: Long term remission assessed through questionnaires
timeFrame: one year after FMT
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
Study officials:
References:
Clinical trial NCT04519372: SARS-CoV-2 /COVID-19 Admission Screening in a University Hospital Setting
Official title: SARS-CoV-2 /COVID-19 Admission Screening in a University Hospital Setting (Covid-Screen Quality Control Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV-2
Keywords: Screening
asymptomatic
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 4099
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population is defined as all patients with an inhospital casenumber and a screening swab for SARS-CoV-2 at the University Hospital Basel from April 1st, 2020 to June 14th, 2020.

Brief summary: The proportion of asymptomatic carriers of SARS-CoV-2 remains elusive, so the potential benefit of systematic screening during the SARS-CoV-2-pandemic is controversial. We investigate the proportion of asymptomatic inpatients who were identified by systematic screening for SARS-CoV-2 upon hospital admission.

Adult patients admitted to the University Hospital Basel from 01.04.-14.06.2020 were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs.

Each patient screened during the study period was retrospectively classified symptomatic or asymptomatic for COVID-19 based on medical chart review.


Eligibility criteria: Inclusion Criteria:

* The patient population is defined as all adult patients hospitalized in the University Hospital Basel from April 1st, 2020 to June 14th, 2020.

Exclusion Criteria:

* Outpatients
* Patients with SARS-CoV-2 screening in the outpatient test center
* Patients with a SARS-CoV-2 test more than 72 hours before hospital admission
* Test not performed (for any reason)

Primary outcomes:
measure: Proportion of SARS-CoV-2 -infected patients
timeFrame: 01.04.2020-14.06.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Study officials:
affiliation: University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
name: Sarah Tschudin-Sutter, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229372: Prolonged Exposure Versus Treatment as Usual in Chronic Posttraumatic Stress Disorder Combat and Terror Related Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic Posttraumatic Stress Disorder (PTSD)


Eligibility criteria: Inclusion Criteria:

* PTSD

Exclusion Criteria:

* Psychotic symptoms
* Dissociation
* Drug or Alcohol dependence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Nitza Nacasch, MD
role: STUDY_CHAIR
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nacasch N, Foa EB, Huppert JD, Tzur D, Fostick L, Dinstein Y, Polliack M, Zohar J. Prolonged exposure therapy for combat- and terror-related posttraumatic stress disorder: a randomized control comparison with treatment as usual. J Clin Psychiatry. 2011 Sep;72(9):1174-80. doi: 10.4088/JCP.09m05682blu. Epub 2010 Nov 16.
Clinical trial NCT03081572: Platelet Function on Abacavir and Tenofovir
Official title: Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Platelet Aggregation, Spontaneous
HIV/AIDS
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir

Brief summary: This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients.

This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* Stable antiretroviral regimen for \> 3months containing either abacavir or tenofovir
* Suppressed HIV viral load

Exclusion Criteria:

* Current cigarette smoking
* Pre-existing platelet disorder
* current or recent (last 6 months) antiplatelet therapy
* pregnancy

Primary outcomes:
measure: Platelet aggregation
timeFrame: At screening visit
Secondary outcomes:
measure: Plasma Markers of coagulation
timeFrame: At screening visit
measure: Plasma Markers of Coagulation
timeFrame: At screening visit
measure: Plasma markers of endothelial function
timeFrame: At screening visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical AIDS Research and Education Center
state: California
Study officials:
References:
Clinical trial NCT03799172: Echinocandins Versus Azoles for Candidemia Treatment
Official title: Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 79
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: Patients with a diagnosis of candidemia during their ICU stay

Brief summary: Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.


Eligibility criteria: Inclusion Criteria:

* Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles

Exclusion Criteria:

* Patients with neutropenia
* Patients without antifungal treatment
* Patients who received antifungal therapy for more than two days before candidemia diagnosis
* Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
* Patients who received less than 4 days of antifungal therapy after candidemia diagnosis

Primary outcomes:
measure: Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
timeFrame: Mortality on day 90 after antifungal initiation
Secondary outcomes:
measure: Comparison of treatment success on day 30 between echinocandins and azoles.
timeFrame: Treatment success on day 30 after antifungal initiation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT00954772: Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation
Official title: Mood and STN Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Keywords: Staged versus Simultaneous Bilateral DBS
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Parkinson Foundation
First posted: 2009-08-07
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients who undergo STN DBS

Brief summary: The purpose of this research study is to investigate any changes seen in mood or behavior following deep brain stimulation for movement disorders.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD diagnosed by a movement disorders neurologist
* Approved by a movement disorders neurologist as clinically needing a DBS device
* Absence of significant cognitive dysfunction (Mattis Dementia Rating Scale Score of greater than or equal to 116)
* MRI without evidence of structural abnormality (stroke, tumor, malformation, etc)
* No prior neurosurgical intervention

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
Study officials:
affiliation: University of Florida
name: Michael S Okun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04848272: Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
Official title: Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lung Injury
Lead sponsor: St Vincent's Institute of Medical Research
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open-label placebo-controlled dose-escalation Phase 1 study
Primary purpose: TREATMENT

Brief summary: Phase 1 study investigating safety of lanadelumab administration to patients with lung injury

Detailed description: This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) ≤92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) ≤300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.
* Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.
* Arterial cannula in place as part of usual care for the measurement of blood gases.
* Patients may or may not be intubated and mechanically ventilated.
* Able to provide informed consent, or if unable to do so, a responsible person:

medical treatment decision maker is available (by telephone if necessary) who can be approached to seek consent.

Exclusion Criteria:

* Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.
* Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.
* Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.
* Previously enrolled in this study.
* Enrolled in another study.
* Usually receives home oxygen.
* Usually receives any type of assisted ventilation at home. e.g. continuous positive airway pressure for obstructive sleep apnoea.
* Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is negative.
* Objection from the treating clinician.
* Consent refused by the patient or substitute decision maker.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Blood bradykinin concentration
timeFrame: 0, 6, 12, and 24 hours
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
Study officials:
References:
Clinical trial NCT03853772: The Johns Hopkins Heartburn Center Registry
Official title: The Johns Hopkins Heartburn Center Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastroesophageal Reflux Disease
Barrett Esophagus
Laryngopharyngeal Reflux
Esophagitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: EndoGastric Solutions
First posted: 2019-02-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred by physicians having diagnostic evaluation or treatment for GERD.

Brief summary: A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

Detailed description: This registry is a prospective, multicenter registry of patients undergoing diagnostic evaluation and/or treatment of gastroesophageal reflux disease and associated diseases and complications.

Patients who are eligible will have disease and therapy-specific data collected throughout treatment and long-term (5-year) follow-up.

Electronic data capture via REDCap will be utilized for all sites.

Eligibility criteria: Inclusion Criteria:

* Referred GERD patients willing to participate in long term follow-up (5 years)

Exclusion Criteria:

* Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry

Primary outcomes:
measure: Demographic and clinical data obtained via chart review and questionnaires
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI-Irvine
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Reno
country: United States
facility: UNRMed-University of Nevada, Reno
state: Nevada
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Bay City
country: United States
facility: The Matagorda Regional Medical Group
state: Texas
city: Houston
country: United States
facility: UT Health
state: Texas
city: Appleton
country: United States
facility: Fox Valley Surgical Associates
state: Wisconsin
Study officials:
affiliation: Johns Hopkins University
name: Marcia Canto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01767272: Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers
Official title: Dose Proportionality of Fexofenadine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Fexofenadine
Pharmacokinetics
Bioavailability
Linearity
HPLC
Dose proportionality of fexofenadine in Egyptian volunteers
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after oral administration.

Detailed description: The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after administration of single oral doses of 60 to 360 mg in an open-label, five-way crossover study.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* A history of serious intolerance, allergy, or sensitivity to fexofenadine
* The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
* Cannot follow instructions, in the opinion of the investigator.

Primary outcomes:
measure: Tolerability
timeFrame: Participants will be followed for the duration of study, an expected average of 5 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: