louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02971111: Thromboelastometry in Assessment of Sepsis Coagulopathy
Official title: Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombelastography
Sepsis
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2016-11-22
Enrollment: 76
Sex: ALL
Minimum age (years): 24
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with sepsis who underwent invasive procedures

Brief summary: The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results


Eligibility criteria: Inclusion Criteria:

* sepsis/septic shock
* prolonged PT-INR (international normalized ratio) ≥ 1.3
* normal ROTEM-EXTEM results.

Exclusion Criteria:

* patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K antagonists...)
* patients with cirrhosis

Primary outcomes:
measure: incidence of bleeding complications
timeFrame: 2013 - 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lukas P, Durila M, Jonas J, Vymazal T. Evaluation of Thromboelastometry in Sepsis in Correlation With Bleeding During Invasive Procedures. Clin Appl Thromb Hemost. 2018 Sep;24(6):993-997. doi: 10.1177/1076029617731624. Epub 2017 Sep 26.
Clinical trial NCT00454311: The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening
Official title: Prospective and Randomized Study of the Impact of the Biopsy of 1-2 Cells in a PGD Program for Aneuploidy Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pregnancy and implantation rates
Efficiency and accuracy of the genetic testing
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-03-30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This prospective and randomized study will be performed at the Instituto Valenciano de Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing PGD for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, X \& Y

Exclusion Criteria:

* Patients undergoing PGD for monogenic diseases (PCR)
* Patients undergoing PGD for structural chromosomal abnormalities
* Ovum donation cycles
* Cryopreserved oocyte/embryos

Primary outcomes:
measure: impact of biopsy
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de la Infertilidad
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Carmen Rubio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646411: 300 Antibody Diagnostic Test Kit
Official title: Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Bacterial Infections
Acute Viral Infections
Keywords: cytomegalovirus (CMV) IgM &IgG
Lyme
Toxoplasma
Rubella
Rubeola IgM
Rocky mountain Spotted Fever IgM
Ebv IgM
Herpes
Babesia
Measles
Tetanus
Mumps
Mycoplasma
Legionella
Giardia
Syphilis
Bordetella Pertussis
H Pylori
Antibody Titre
Elevated IgG
Abnormal IgM
SLE
Lead sponsor: The Plasma Source
Sponsor class: INDUSTRY
Collaborators: name: Plasma Services Group
First posted: 2012-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute infection between the age of 18 and 70. Sex and race are random.

Brief summary: For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.


Eligibility criteria: Inclusion Criteria:

* current acute infection
* age 18-70
* male or female
* any race
* currently active symptoms

Primary outcomes:
measure: IgM greater than 1xcut off value
timeFrame: Antibody value measured within seven days of specimen collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United States
facility: The Plasma Source
state: Pennsylvania
Study officials:
name: Jeffery Flieshman, M.S immunology
role: STUDY_DIRECTOR
References:
Clinical trial NCT00525811: Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Low Back Pain
Depression
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Shared decision making (SDM) has been advocated as an appropriate approach for physician patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater treatment adherence, lower decisional conflict and better clinical outcomes. The Section of Clinical Epidemiology and Health Services Research at the University Medical Center in Freiburg (Germany) is developing and evaluating a web-based interactive decision aid ("patient dialogue") to support shared decision making in cooperation with the Techniker Krankenkasse, a large German health insurance company. Both development and evaluation are conducted along the International Patient Decision Aid Standards (IPDAS).

The decision aid contains information on acute low back pain and depression and addresses insurance members who are facing a treatment decision in one of the indications. It aims at the development of patient competencies for participating in decision making, the support of constructive health behavior and patients' acceptance of evidence based treatment options.

In an RCT the decision aid will be compared to a regular patient information on a sample of N=500 patients in each group. Data collection will take place at three points of time: before and after use of the decision aid as well as 3 months later.


Eligibility criteria: Inclusion Criteria:

* insurance members with acute low back pain or depression

Exclusion Criteria:

* insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms

Primary outcomes:
measure: Decisional conflict
timeFrame: After using the decision aid
Secondary outcomes:
measure: Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence
timeFrame: After using the decision aid and 3 months later respectively
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center
Study officials:
affiliation: University Medical Center, Freiburg, Germany
name: Martin Haerter, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04899011: Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life
Official title: Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ear Middle Problems
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 214
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 middle ear surgery

Brief summary: Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.

CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.

Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.

We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.

We will evaluate the Influence of type of CTN injury on taste disturbance.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing middle ear surgery
* Acceptation to participate
* under 18 years old, parental authorization.

Exclusion Criteria:

* Taste disturbance before surgery
* Patients with guardianship or tutelage measure

Primary outcomes:
measure: Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life.
timeFrame: 1 year
Secondary outcomes:
measure: Influence of CTN injury type: stretch versus sectionned, influence of otologic desease
timeFrame: 1 day
measure: Influence of use between endoscope or microscope surgery
timeFrame: 1 day
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Nicolas GUEVARA, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05690711: A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction
Official title: Efficacy and Safety of Intravenous HRS8179 on Brain Swelling After Large Hemispheric Infarction: a Randomised, Double-blind, Placebo-controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Swelling, Large Hemispheric Infarction
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 40
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: TREATMENT

Brief summary: The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.


Eligibility criteria: Inclusion Criteria:

1. Fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative);
2. Aged 18\~80, regardless of gender;
3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
4. NIHSS ≥ 10 points at screening;
5. A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
6. The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion Criteria:

1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia;
2. CT/MRI suggested that the anterior septal/pineal excursion was \>2 mm due to brain edema;
3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);

Primary outcomes:
measure: The change between baseline and 72-78 hours in midline shift measured by MRI or CT
timeFrame: Baseline up to 72 hours
Secondary outcomes:
measure: modified Rankin Scale (mRS) Score
timeFrame: Day 90
measure: Overall survival
timeFrame: Baseline up to Day 90
measure: Number of Participants Who Achieved mRS 0-4
timeFrame: Day 90
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT05070611: Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
Official title: Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chalazion
Keywords: Chalazion
IPL
Meibomian gland function
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 35
Sex: ALL
Minimum age (years): 24
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.

Detailed description: We hypothesized that IPL application on the skin adjacent to eyelids after chalazion surgery will result in better meibomian gland function and lower recurrence. To date, it has not been previously reported the outcomes of the use of this technology for the management of chalazions recurrence. The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.

Eligibility criteria: Inclusion Criteria:

* All patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments.

Exclusion Criteria:

* (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.

Primary outcomes:
measure: Recurrence rate of chalazia
timeFrame: an average of 1 year
Secondary outcomes:
measure: NITBUT
timeFrame: an average of 1 year
measure: meibomian expressibility and quality
timeFrame: an average of 1 year
measure: TMH
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University Hospital
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University Hospital
name: lin lin
role: STUDY_CHAIR
References:
Clinical trial NCT00428428: Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
Official title: Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Stone
Unexplained Haematuria
Benignant Tumour Mass in the Upper Urinary Tract
Keywords: kidney stone
ureteroscopy
Lead sponsor: Fredericia Hosptial
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.


Eligibility criteria: Inclusion Criteria:

* Indication for ureterorenoscopy
* Age\> 18 years
* Normal blood pressure

Exclusion Criteria:

* Malignant disease in the upper urinary tract
* Heart disease
* Allergy to Isoproterenol
* Use of α-blocking or β-blocking medicine
* Use of Calcium-antagonists
* Use of NSAIDs the last 48 hours
* Present stone or JJ-stent in the ureter
* Neurologic disease in the bladder
* Pregnancy
* Nursing mothers

Primary outcomes:
measure: pelvic pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Fredericia
country: Denmark
facility: Dp. of Urology, Fredericia & Kolding Hospitals
Study officials:
affiliation: Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark
name: Palle JS Osther, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00115128: Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
Official title: Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal PBPC Donors
Keywords: normal PBPC donors
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-22
Enrollment: 309
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: Normal donors

Brief summary: The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.


Eligibility criteria: Inclusion Criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution Exclusion Criteria: - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF

Primary outcomes:
measure: Spleen fold change measured by ultrasound
timeFrame: Before, during, and through 1 week post-PBPC mobilization and collection
Secondary outcomes:
measure: Spleen change associations with filgrastim dose and hematologic variables
timeFrame: Before, during, and through 1 week post-PBPC mobilization and collection
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Stiff PJ, Bensinger W, Abidi MH, Gingrich R, Artz AS, Nademanee A, Hansen KS, Sobczak C, Cutler C, Bolwell B, Shore TB, Lazarus HM, Yeager AM, Lovelace W, Guo M, Dreiling L. Clinical and ultrasonic evaluation of spleen size during peripheral blood progenitor cell mobilization by filgrastim: results of an open-label trial in normal donors. Biol Blood Marrow Transplant. 2009 Jul;15(7):827-34. doi: 10.1016/j.bbmt.2009.03.015.
Clinical trial NCT01433328: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Official title: Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: Remodulin
Treprostinil
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.


Eligibility criteria: Inclusion Criteria:

* PAH
* Treprostinil treatment for at least 3 months
* Severe infusion site pain

Exclusion Criteria:

* Pregnancy/breastfeeding
* Decompensated heart failure
* Chronic liver disease
* Abnormal electrolytes
* Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
* Systolic systemic BP \<90mmHg
* Bradycardia HR \<55
* Adverse reaction to lidocaine or other amide local anesthestic
* Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)

Primary outcomes:
measure: Pain Questionnaire
timeFrame: 1 week
measure: Daily Pain Diary
timeFrame: 1 week
Secondary outcomes:
measure: proNT-BNP
timeFrame: 1 week
measure: 6 minute walk
timeFrame: 1 week
measure: Lidocaine level
timeFrame: 1 week
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Chair, Cardiology Department
name: David Langleben, MD
role: PRINCIPAL_INVESTIGATOR
References: