louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03026023: Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
Official title: A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cardiac Transplant Disorder
Hepatitis C
Keywords: Heart Transplant
Cardiac Transplant
Hepatitis C
Zepatier
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-01-20
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: PREVENTION

Brief summary: This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.

Detailed description: Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.

Patients will be selected based on their diminished likelihood of receiving a heart from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.

Eligibility criteria: Inclusion Criteria:

* Recipient is Age ≥ 18 years
* Serum ALT within normal limits with no history of liver disease
* Lack of sensitization (i.e. PRA \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria:

* Sensitization (i.e. PRA \>20%)
* Any liver disease in recipient
* Albumin \< 3g/dl or platelet count \< 75 x 103/mL
* Need for dual organ transplant

Primary outcomes:
measure: Undetectable HCV
timeFrame: 12 Weeks post treatment
Secondary outcomes:
measure: Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation
timeFrame: Upto 16 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Masschusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond T Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02112123: Icariin to Prevent Corticosteroid-related Memory Changes
Official title: Icariin to Prevent Corticosteroid-related Memory Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: the Pharmacokinetic Profile of Icariin in Humans
Keywords: icariin
pharmacokinetics
healthy participants
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.

Detailed description: The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.

Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.

24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Ages 18 - 50 years
* BMI between 18.5 and 30
* Ability to read and speak English
* Education of 12 or more years or equivalent (at least GED received)

Exclusion Criteria:

* Medication changes in the past 30 days
* History of psychotropic medication therapy in the past 30 days
* Current or past 30 days opioid therapy
* Current or past 30 days erectile dysfunction therapy
* Significant medical conditions
* Hypertensive blood pressure, defined as either systolic pressure \> 140 or diastolic pressure \> 90
* Baseline heart rate \> 100 bpm or \< 50 bpm
* History of major psychiatric illness
* History of drug/alcohol abuse or current tobacco use
* Vulnerable populations including pregnant or nursing women, the incarcerated, or individuals with severe cognitive disorders
* History of allergic reaction or contraindication to icariin
* Baseline QIDS score \> 7, current suicidal ideation, or history of suicide attempt
* Education history that includes Special Education or history of mental disability
* Clinically significant abnormalities on baseline labs and ECG results
* Current participation in any other pharmacotherapy studies

Primary outcomes:
measure: Blood concentration levels of icariin
timeFrame: 24 hours
Secondary outcomes:
measure: A-SEX
timeFrame: 5 days
measure: SAFTEE
timeFrame: 5 days
measure: PT/PTT levels
timeFrame: 5 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: E. Sherwood Brown, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631423: Evaluation of Patients With Vena Cava Inferior Thrombosis
Official title: Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inferior Vena Cava Thrombosis
Venous Thromboembolism
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with venous thrombosis involving the inferior cava inferior obtained from the Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our department are registered

Brief summary: The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.

Detailed description: All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.

Eligibility criteria: Inclusion Criteria:

* age 18-90 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Recurrent venous thromboembolism
timeFrame: 6, 12, 24 and 60 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 6, 12, 24 and 60 months
measure: Post-thrombotic syndrome
timeFrame: 24 and 60 months
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
name: Birgit Linnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05085223: Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients
Official title: Development of Hypernatremia in Critically Ill Patients: Prospective Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypernatremia
Critical Illness
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the Intensive Care Unit.

Brief summary: Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.

This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.


Eligibility criteria: Inclusion Criteria:

* Admitted to Intensive Care Unit
* Age 18 years or older

Exclusion Criteria:

* Age 17 years or younger

Primary outcomes:
measure: Hypernatremia
timeFrame: During admission in ICU
Secondary outcomes:
measure: 24 hour urine replacement for spot-checks
timeFrame: 24 hours
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
state: Noord-Brabant
Study officials:
References:
citation: Mestrom EHJ, van der Stam JA, Te Pas ME, van der Hoeven JG, van Riel NAW, Bindels AJGH, Boer A, Scharnhorst V. Increased sodium intake and decreased sodium excretion in ICU-acquired hypernatremia: A prospective cohort study. J Crit Care. 2021 Jun;63:68-75. doi: 10.1016/j.jcrc.2021.02.002. Epub 2021 Feb 10.
Clinical trial NCT02841423: Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery
Official title: Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients ASA I, II, III
Keywords: physical status I-III;
age > 55 yr)
undergoing surgery (duration, > 1 h)
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 204
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.

Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, \> 55 yr) undergoing surgery (duration, \> 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III;
* undergoing surgery (duration, \> 1 h)

Exclusion Criteria:

-

Primary outcomes:
measure: the incidence of early POCD in elderly patients (aged 55 yrs or older)
timeFrame: 3 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chu Besancon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: E SAMAIN, PR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besch G, Vettoretti L, Claveau M, Boichut N, Mahr N, Bouhake Y, Liu N, Chazot T, Samain E, Pili-Floury S. Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. Medicine (Baltimore). 2018 Oct;97(40):e12558. doi: 10.1097/MD.0000000000012558.
Clinical trial NCT01603823: Angiographie and OCT in Macula and Retinal Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Keywords: vitrectomy
cataract
macular edema
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty eyes of 20 patients with previous 23-gauge PPV and ILM peeling (PPV group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.

Brief summary: The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases.

Detailed description: Recently, a new generation of OCT devices relying on spectral domain technology (SD-OCT) has been introduced and allows for higher-resolution imaging. Based on this technology we can identify variable changes at the retinal surface such as, retinal thickening with cyst formation, swelling in the inner and outer nuclear layers and subretinal fluid. The introduction of an eye-tracking mode has allowed a better insight into the development of retinal morphologic changes The aim of this study was to investigate the incidence and structural morphology of PCME after successful uncomplicated cataract surgery in patients with previous pars plana vitrectomy (PPV) and indocyanine green-assisted peeling of an epiretinal membrane and the internal limiting membrane (ILM).

Eligibility criteria: Inclusion Criteria:

* previous 23-gauge PPV and ILM peeling

Exclusion Criteria:

* history of branch retinal vein occlusion
* central retinal vein occlusion
* wet macular degeneration
* diabetic retinopathy
* uveitis or other inflammatory eye disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Mylonas G, Sacu S, Deak G, Dunavoelgyi R, Buehl W, Georgopoulos M, Schmidt-Erfurth U; Macula Study Group Vienna. Macular edema following cataract surgery in eyes with previous 23-gauge vitrectomy and peeling of the internal limiting membrane. Am J Ophthalmol. 2013 Feb;155(2):253-259.e2. doi: 10.1016/j.ajo.2012.07.013. Epub 2012 Oct 1.
Clinical trial NCT03627650: Fat Grafting in Skin-grafted Deep Burn Scars
Official title: Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scar
Keywords: burn
scar
fat
grafting
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled trial
Primary purpose: TREATMENT

Brief summary: fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up

Detailed description: Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.

Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.

Eligibility criteria: Inclusion Criteria:

* early skin-grafted deep burn scars
* otherwise healthy

Exclusion Criteria:

* concomitant disease

Primary outcomes:
measure: Improvement of scar quality by histological assessment
timeFrame: 6 months
measure: improvement of scar quality by physiological testing with cutometer
timeFrame: 6 months, 1 year
measure: Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
timeFrame: 1 year
measure: Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale
timeFrame: 1 year
measure: improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)
timeFrame: 6 months, 1 year
measure: physiological testing of scar tissue by corneometer
timeFrame: 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UGent University Hospital
name: Maarten AJ Doornaert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876850: Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Official title: A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Skin Structures and Soft Tissue Infections
Keywords: cSSI
Abscess
Would
Cellulitis
Complicated Skin and Skin Structure Infections (cSSSI)
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 0
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: A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Detailed description: The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility criteria: Inclusion Criteria:

* Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
* Patients, ages 18 years or older
* Is expected to require greater than or equal to 4 days antibiotic therapy
* Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Has received an investigational drug within the past 1 month
* Has been previously enrolled in this protocol
* Has received \>48hr of potentially effective systemic antibiotic immediately prior to study drug
* Is nursing

Primary outcomes:
measure: Clinical success at follow-up
timeFrame: 4 weeks after enrollment
Secondary outcomes:
measure: To evaluate safety of dosing regimens
timeFrame: 4 weeks after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Paratek Pharmaceuticals Inc
name: Robert Arbeit, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01184950: Virtual Reality Laparoscopy Training
Official title: Prospective Randomized Trial of Virtual Reality Simulator Training in an Obstetrics and Gynecology Residency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Differences in OSATS Scores
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2010-08-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: OTHER

Brief summary: The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.


Eligibility criteria: Inclusion Criteria:

* Resident in OB/Gyn at TriHealth

Exclusion Criteria:

* None

Primary outcomes:
measure: observed structured assessment of technical skills (OSATS) Score
timeFrame: 0 Months
Secondary outcomes:
measure: observed structured assessment of technical skills (OSATS) score
timeFrame: 4 Months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
References: