louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05189041: Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
Official title: Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aneurysm
Keywords: aneurysm
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.

Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.


Eligibility criteria: Inclusion Criteria:

* Age limits to \> 18 years
* Collection of the informed consent (patient or legal representant)
* Affiliation or recipient with the mode of social security

  - Groupe anévrysme rompu
* Patient porteur d'un anévrysme rompu

  - Groupe anévrysme non rompu
* Patient porteur d'un anévrysme non rompu

Exclusion Criteria:

* Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker ...)
* Claustrophobia
* Women pregnant or Breast-feeding
* Patient participating in an other study
* Patient have participated in a study in the 3 months before the inclusion
* In period of exclusion relative to another protocol
* Person with majority age protected by the law (supervision or trusteeship).
* Patient not reading the french language
* Patient or representant for whom it impossible to give accurate informations

Primary outcomes:
measure: Quantify the aneurysmal pulsation in functional MRI
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: COSTALAT
Study officials:
affiliation: University Hospital, Montpellier
name: VINCENT COSTALAT
role: STUDY_DIRECTOR
References:
Clinical trial NCT00982241: Overactive Bladder (OAB) Drink Advice Study
Official title: Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: OAB
urine
osmolality
urge
fluid intake
PPIUS
urge score
bladder
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.


Eligibility criteria: Inclusion Criteria:

* OAB patients

Exclusion Criteria:

* benign prostatic hyperplasia
* neurogenic detrusor overactivity
* urine tract infection
* anticholinergics
* intravesical botulin toxin
* cardiac failure
* renal insufficiency
* sacral neurostimulation
* percutaneous neurostimulation

Primary outcomes:
measure: urine osmolality
timeFrame: 2 days
measure: PPIUS urge-score
timeFrame: 2 days
Secondary outcomes:
measure: urine pH
timeFrame: 2 days
measure: PPIUS urge score
timeFrame: 2 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Dept. of Urology, Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: dept of Urology, Radboud University Nijmegen Medical Centre
name: John Heesakkers, dr. MD
role: STUDY_CHAIR
References:
Clinical trial NCT01048541: Bladder Scan of Residual Urine With New Catheter
Official title: A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

1. Subject is a male IC user able to self-catheterise
2. Subject has used hydrophilic-coated ICs for at least 1 month
3. Subject is at least 18 years old.
4. Subject has provided informed consent.

Exclusion Criteria:

1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease).
2. Subject has known abnormalities in the lower urinary tract.

Primary outcomes:
measure: Mean Residual Urine Volume
timeFrame: 3 catheterisations on 1 day
Secondary outcomes:
measure: The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)
timeFrame: Study period
measure: Median Absolute RU Volume
timeFrame: 3 catheterisations on 1 day
Other outcomes:
Locations:
city: Bad Wildungen
country: Germany
facility: Werner-Wicker-Klinik, Abteilung für Neuro-Urologie
state: Hessen
Study officials:
affiliation: Werner Wicker Klinik
name: Burkhard Domurath, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Coloplast A/S
name: Henrik S Knoth, M.Sc Pharm
role: STUDY_DIRECTOR
References:
citation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
citation: Domurath B, Kutzenberger J, Kurze I, Knoth HS. Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation. Spinal Cord. 2011 Jul;49(7):817-21. doi: 10.1038/sc.2011.14. Epub 2011 Mar 1.
Clinical trial NCT03443141: Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery
Official title: Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, randomized study will be performed. Patients are randomized using a 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). The primary outcomes variable will be occurrence of incisional SSI. Follow-up will be 30 days postoperatively.

Detailed description: A prospective, randomized study will be performed. Patients are randomized using a random number table into 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). In group 1 the wound will be covered with a Vitamin E embebbed gauze and plastic adhesive tape. In Group 2, , the wound will be covered with standard gauze and plastic adhesive tape.

The primary outcomes variable will be occurrence of incisional SSI, defined by CDC criteria. Follow-up will be 30 days postoperatively.

Eligibility criteria: Inclusion Criteria:

* diagnosis of colorectal neoplasms
* plan to undergo an elective operation with curative aims
* laparoscopic surgery

Exclusion Criteria:

* Anastomotic leak
* Lost to 30-days follow-up

Primary outcomes:
measure: Incisional surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital general Universitario de Elche
state: Alicante
Study officials:
affiliation: HOSPITAL REY JUAN CARLOS
name: Damian Garcia-Olmo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04146441: Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma
Official title: Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Contrast agent BR
SonoVue
Ultrasonic therapy
Microbubbles
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.


Eligibility criteria: Inclusion Criteria:

* Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
* eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
* ECOG 0 - 1

Exclusion Criteria:

* Known contraindications for SonoVue
* Hematological bleeding status before experimental treatment:
* Hb \< 8g/dL, trc \< 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
* Pregnancy

Primary outcomes:
measure: Volume change of primary tumor
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of down-staged tumors from stage III to stage II
timeFrame: 8 weeks
measure: Number of down-staged tumors from stage III to stage II
timeFrame: 1 year
measure: Rate of reported toxicity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Radiology, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Eva Hofsli, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01573741: Study of Ketamine as an Antidepressant in Major Depressive Disorder
Official title: Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Keywords: depressive ketamine antidepressant
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Outcome Measures:

Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.

Secondary Outcome Measures:

Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation.


Eligibility criteria: Inclusion Criteria:Male patients, ages 18 to 65 years with a diagnosis of MDD, currently depressed or in a current major depressive episode of BD without psychotic features will be recruited into this substudy.

Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.

Exclusion Criteria:Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using oher antidepressant drugs in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.

Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.

Clinically significant abnormal laboratory tests.

Subjects with clinical hypothyroidism or hyperthyroidism.

Subjects with one or more seizures without a clear and resolved etiology.

Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).

Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score

Primary outcomes:
measure: all cause remission
timeFrame: 7day
Secondary outcomes:
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The PLA 102nd Hospital and mental health center of military
state: Jiangsu
Study officials:
affiliation: Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University
name: Jianjun Yang, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT02694341: Bakri Balloon in Placenta Previa
Official title: Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bleeding
Placenta Previa
Keywords: Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.


Eligibility criteria: Inclusion Criteria:

1. All women delivered and presented with primary atonic PPH
2. Women who accepted to participate

Exclusion Criteria:

1. Traumatic PPH as excluded by examination under anesthesia.
2. With any suspected or clinical evidence of uterine infection
3. Women diagnosed to have preeclampsia or eclampsia after delivery.
4. Women who had DM during pregnancy
5. Women with history of DVT or other thromboembolic complication
6. Women with history of rheumatic heart disease.
7. Women with coagulation defects.

Primary outcomes:
measure: Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
citation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
Clinical trial NCT00544141: Clinical Evaluation of the Care On Line Thermometer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Temperature measurement
Lead sponsor: Medisim Ltd
Sponsor class: INDUSTRY
First posted: 2007-10-16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Children (1-18 years old) in the pediatric or emergency department, with or without fever.

Brief summary: The purpose of this clinical study is to evaluate the performance of the COL thermometer by comparing its measurement to equilibrium measurement and to make a final tuning of the thermometer algorithm.


Eligibility criteria: Inclusion Criteria:

* Children (1-18 years old) in the pediatric or emergency department, with or without fever.
* An informed consent was signed by the patient's guardian.

Exclusion Criteria:

* The medical staff decides that participating will damage patient recovery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah TIkva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Yehezkel Waisman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724941: Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
Official title: Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Prodromal
Alpha-Synuclein
Risk disclosure
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: UCB Biopharma SRL
name: University of Kiel
First posted: 2021-01-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.

Detailed description: The PASS-PP Study is designed to combine the latest developments in clinical and biomarker research to

1. understand the distribution of risk profiles for PD in the general population, especially regarding non-motor symptoms
2. identify subjects with a likelihood of developing PD
3. follow individuals with a high likelihood/risk to develop PD in the future (compared to individuals with low risk and) in a prospective study
4. understand the potential of biological markers to increase prediction of progression/conversion
5. identify subtypes of PD patients, by providing a detailed clinical phenotyping with a main focus on non-motor symptoms cluster
6. provide a framework of ethical handling of early risk disclosure in PD

Eligibility criteria: Inclusion Criteria:

* Age between 50 and 99

Exclusion Criteria:

* Presence of clinical PD at the time of study inclusion
* Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis)
* other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment
* in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)

Primary outcomes:
measure: Risk marker profile
timeFrame: Analysis after three years.
Secondary outcomes:
measure: Non-motor and motor symptoms
timeFrame: Analysis after three years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department for Neurology, University of Kiel
Study officials:
affiliation: Department for Neurology, University of Kiel
name: Daniela Berg, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401141: Abnormalities of B Lymphocytes During Systemic Lupus
Official title: Phenotypic Characteristics and Transcriptomas of B Lymphocytes During Non Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus
B lymphocytes
transcriptomas
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities during lupus in mice spontaneously affected by the disease. This study tries to define these abnormalities by looking at the gene expression profile of purified B lymphocytes from patients with non active systemic lupus , compared with the gene expression profile of purified B lymphocytes from healthy donnors.


Eligibility criteria: Inclusion criteria:

* non active systemic lupus

Exclusion criteria:

* immunosuppressive drugs
* more than 10 mg of prednisone per day

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Immunologie Clinique et VIH - Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jean-Louis Pasquali, MD
role: STUDY_DIRECTOR
References: