louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00756145: The Use of Low Molecular Weight Heparin in Hemodiafiltration
Official title: The Use of Low Molecular Weight Heparin in Hemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: stage V
treated
hemodiafiltration
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease stade V treated with hemodiafiltration
* age \>18 year
* Hematocrit \> 30%

Exclusion Criteria:

* treatment with vitamin K antagonists
* treatment with other anti-coagulants or heparin besides the heparin used during dialysis
* active bleeding, infection or malignancy
* heparin associated allergy
* hepatic failure
* trombocytopenia \< 120.000/µl

Primary outcomes:
measure: Anti-Xa activity at the end of the session
timeFrame: 240 min after start
Secondary outcomes:
measure: Anti-Xa activity during the session
timeFrame: at start, 30 min, 120 min and 180 min
measure: ETP during the session
timeFrame: at start, 30 min, 120 min, 180 min and 240 min
measure: Reduction ratio of urea
timeFrame: after 10min, 180min and 240min
measure: Reduction ratio of beta2microglobulin
timeFrame: after 10min, 180min and 240min
measure: Visual inspection of membrane and circuit
timeFrame: After the hemodiafiltration session
measure: pressure measurements along the circuit
timeFrame: during the session
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Annemieke Dhondt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhondt A, Pauwels R, Devreese K, Eloot S, Glorieux G, Vanholder R. Where and When To Inject Low Molecular Weight Heparin in Hemodiafiltration? A Cross Over Randomised Trial. PLoS One. 2015 Jun 15;10(6):e0128634. doi: 10.1371/journal.pone.0128634. eCollection 2015.
Clinical trial NCT03674645: Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research
Official title: Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Magnetic Resonance Imaging Sequences
Keywords: Healthy volunteers
Test
Optimization
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
First posted: 2018-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

Detailed description: The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (over 18 yo),
* Male or female,
* Affiliated to social security,
* Without any contraindication to MRI exam and who will have signed a written inform consent.

Exclusion Criteria:

* Individuals deprived of liberty,
* Under guardianship or curatorship,
* Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
* Pregnant women,
* Breastfeeding women,
* Women without effective contraception,
* Participants who refused to be informed of the possible discovery of a significant anomaly,
* Persons involved in an interventional study with a drug or an implantable device.

Primary outcomes:
measure: Image quality
timeFrame: Day 0
measure: Signal to noise ratio
timeFrame: Day 0
measure: Contrasts between structurally different regions
timeFrame: Day 0
measure: Total acquisition time
timeFrame: Day 0
measure: Qualitative interpretation of image quality to respiratory and cardiac motions
timeFrame: Day 0
measure: Quantitative interpretation of image quality to respiratory and cardiac motions
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Hubert COCHET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170845: Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
Official title: A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophagectomy
Postoperative respiratory complications
neutrophil elastase inhibitor
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 31
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.

Detailed description: The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.

Eligibility criteria: Inclusion Criteria:

* Thoracic esophageal squamous cell carcinoma

Exclusion Criteria:

* Preoperative chemoradiotherapy
* Cardiovascular disease with NYHA grade III or IV
* Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo
* Liver cirrhosis
* Renal failure

Primary outcomes:
measure: Pulmonary function
timeFrame: 9 days
Secondary outcomes:
measure: Pulmonary function
timeFrame: 9 days
measure: Pulmonary function
timeFrame: 9 days
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Chikara Kunisaki
state: Kanagawa
Study officials:
affiliation: Yokohama City University Medical Center
name: Chikara Kunisaki, MD,PhD
role: STUDY_CHAIR
References:
citation: Makino H, Kunisaki C, Kosaka T, Akiyama H, Morita S, Endo I. Perioperative use of a neutrophil elastase inhibitor in video-assisted thoracoscopic oesophagectomy for cancer. Br J Surg. 2011 Jul;98(7):975-82. doi: 10.1002/bjs.7499. Epub 2011 May 9.
Clinical trial NCT04465045: Unexplained Infertility Treated by Hysteroscopy-laparoscopy
Official title: Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unexplained Infertility
Keywords: Ovulation
semen analysis
tubal patency
pelvic ultrasound scan
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In Montpellier University center only, France : from january 2013 to december 2018 unexplained infertile couple, trying to conceive for more than one year and operated by laparoscopy-hysteroscopy

Brief summary: Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.


Eligibility criteria: Inclusion criteria:

* 18-43y
* unexplained infertility
* operated from laparoscopy-hysteroscopy at montpellier university hospital

Exclusion criteria:

* an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts
* any non respect to inclusion criterias
* non respect of our definition of unexplained infertility (such as bilateral tubal issue on hysterosalpingograms)

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with miscarriage
timeFrame: 1 day
measure: live birth rate
timeFrame: 1 day
measure: Number of Participants with fœtal losses
timeFrame: 1 day
measure: Number of Participants with ectopic pregnancy
timeFrame: 1 day
measure: Number of Participants with surgical complications
timeFrame: 1 day
measure: Number of Participants with type of surgery
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Claire Vincens, doctor of medecine
role: STUDY_DIRECTOR
References:
Clinical trial NCT03692845: Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
Official title: Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Fusion
Keywords: spine fusion
minimally invasive surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 60
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: TREATMENT

Brief summary: A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.

Detailed description: The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

Eligibility criteria: Inclusion Criteria:

* Adults more than 18 years of age and less than 65 years of age..
* Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
* Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
* Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
* Symptoms not responding to conservative treatment for at least 3 months.

Exclusion Criteria:

* Previous spinal fusion or instrumentation.
* Spinal tumours, infection and fractures.
* Patients with severe osteoporosis
* BMI more than 35.
* Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
* Patients not willing to participate in the study

Primary outcomes:
measure: Oswestry Disability index(Arabic version) 1 month
timeFrame: 1 month
Secondary outcomes:
measure: • Fusion rate as assessed by Bridwell fusion score.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01767545: Dexamethasone-implant for the Treatment of RVO
Official title: Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema Caused by Retinal Vein Occlusion
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.


Eligibility criteria: Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -

Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis

-

Primary outcomes:
measure: The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
timeFrame: 12 months
Secondary outcomes:
measure: Central retinal thickness
timeFrame: 12 months
measure: Lens opacity
timeFrame: 12 months
measure: Saftey of procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dept. of Ophthalmology, LMU Munich
Study officials:
References:
Clinical trial NCT03360045: Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
Official title: The Evaluation of Effectiveness of Nasal Compression With Tranexamic Acid Compared to Simple Nasal Compression and Merocel Packing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tranexamic Acid
Epistaxis
Nasal Packing
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 135
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: Aim of this study is evaluate whether superior nasal compression with tranexamic acid to simple nasal compression and Merocel packing.

In this study, patients who presented with non-traumatic anterior epistaxis to emergency departments will be included in this study. Three different therapy option are created; first, nasal compression with tranexamic acid, second, simple nasal compression without any drugs. And third, packing with Merocel.


Eligibility criteria: Inclusion Criteria:

* Patients with anterior epistaxis older than 18 year and accept to participate in the study

Exclusion Criteria:

* Patients younger than 18 years
* Patients who used anticoagulation therapy
* Patients who have hemodynamically instability
* Traumatic epistaxis
* Patients who have known bleeding disorder

Primary outcomes:
measure: Success rate of interventions to stop bleeding
timeFrame: First 15 minutes
measure: Numbers of patients who needs rescue treatment
timeFrame: After 15 minutes first intervention method.
Secondary outcomes:
measure: Re-bleeding
timeFrame: 24 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Keçiören Training and Research Hospital
Study officials:
References:
citation: Akkan S, Corbacioglu SK, Aytar H, Emektar E, Dagar S, Cevik Y. Evaluating Effectiveness of Nasal Compression With Tranexamic Acid Compared With Simple Nasal Compression and Merocel Packing: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):72-78. doi: 10.1016/j.annemergmed.2019.03.030. Epub 2019 May 9.
Clinical trial NCT00947245: Japanese Bridging Study Conducted in the United States
Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
* First generation Japanese. Subject born in Japan and has not lived outside of Japan for \> 10 years, and subject can trace maternal and paternal Japanese ancestry

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
* Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
* History of eczema, psoriasis, or any intermittent or active dermatitis.
* Positive for HIV or HCV

Primary outcomes:
measure: Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
timeFrame: From time of dose to up to 14 days after last dose
Secondary outcomes:
measure: To measure concentration of study drug following single and multiple doses
timeFrame: Within 48 or 72 hours postdose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Local Institution
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04016545: Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
Official title: Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peri-operative Mortality
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for elective TEVAR treatable with low-profile endoprothesis

Brief summary: The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.


Eligibility criteria: Inclusion Criteria:

* Patients with indications for elective TEVAR

Exclusion Criteria:

* Incapability to provide consent
* Patients not eligible for TEVAR
* Pregnancy

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT00285545: Biomagnetic Signals of Intestinal Ischemia
Official title: Biomagnetic Signals of Intestinal Ischemia II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Blood Supply
Mesentery
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

Detailed description: The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, we hope to identify abnormal disease states without surgery.

Eligibility criteria: Inclusion Criteria:

* Normal Subjects and those diagnosed with mesenteric ischemia

Exclusion Criteria:

* Subjects who report a tendency toward claustrophobia

Primary outcomes:
measure: To observe a difference in the magnetic activity between normal and diseased smooth muscle
timeFrame: 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William O Richards, MD
role: PRINCIPAL_INVESTIGATOR
References: