louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02826395: C11 Sodium Acetate PET/CT Imaging of PCa
Official title: Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostate Cancer
Keywords: Prostate cancer
diagnostic
imaging
PET/CT
Acetate carbon-11
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-07-11
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient management in patients with prostate cancer.

Detailed description: This is an expanded access study under an IND with a total of 300 participants with prostate cancer. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 11C-Sodium Acetate and will undergo a PET/CT imaging study. All patients referred by Oncologists and Urologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate. The following steps will take place.

1. Informed consent will be obtained.
2. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded.
3. Participant will be injected with 20 - 40mCi of 11C-Sodium Acetate intravenously (i.v.).
4. PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, the investigators will acquire a scan. Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
5. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded following the completion of the scan.
6. Within 24-48 hours of PET/CT imaging, a follow-up telephone call or email will be conducted to discuss any side effects or reactions to the investigational agent.

Eligibility criteria: Inclusion Criteria:

* Diagnosed prostate cancer
* Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 200 Medical Plaza, B114
state: California
Study officials:
References:
citation: Czernin J, Benz MR, Allen-Auerbach MS. PET Imaging of Prostate Cancer Using C-Acetate. PET Clin. 2009 Apr;4(2):163-72. doi: 10.1016/j.cpet.2009.05.001. No abstract available.
Clinical trial NCT00447395: Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
Official title: Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Miscarriage
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Couples with recurrent miscarriages

Brief summary: In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast majority of clinical protocols of recurrent miscarriage, the sperm is not considered or assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation and altered oxidative stress in the sperm and Y microdeletions from blood samples have been related to an increased risk of miscarriage.The aim of the present study is to compare these three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact on this reproductive problem.


Eligibility criteria: Inclusion Criteria:

4 groups

* Recurrent miscarriage, \<40 year-old-men, \< 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy
* The same criteria than in group A, but oligozoospermia (1-5 mill/ml)
* Oligozoospermia (1-5 mill/ml), \< 40 year-old-men, no recurrent miscarriages
* Healthy young sperm donors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
affiliation: IVI Valencia
name: Jose Bellver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellver J, Meseguer M, Muriel L, Garcia-Herrero S, Barreto MA, Garda AL, Remohi J, Pellicer A, Garrido N. Y chromosome microdeletions, sperm DNA fragmentation and sperm oxidative stress as causes of recurrent spontaneous abortion of unknown etiology. Hum Reprod. 2010 Jul;25(7):1713-21. doi: 10.1093/humrep/deq098. Epub 2010 May 24.
Clinical trial NCT03780595: Passiflora Extract for Benzodiazepine Withdrawal
Official title: Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benzodiazepine Withdrawal (Disorder)
Keywords: Benzodiazepine
Withdrawal
passiflora
Lead sponsor: Nutricion Medica S.L.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

1. Age \> 65 years old
2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
3. Capable of giving consent and to answer the questionnaires according to researcher criteria

Exclusion Criteria:

1. Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
2. Acute confusional syndrome at the inclusion
3. Panic disorder
4. Obsesive-compulsive disorder
5. Any type of psycosis or bipolar disorder
6. Severe Parkison disease diagnosed
7. Current or past diagnosis of epilepsia
8. Recent stroke (last month)
9. Thyroid disorders not controlled or uncompensated
10. Alteration of deglutition
11. Previous drugs or alcohol abuse
12. Hospitalization (more than 24 hours) during the last month
13. Complex priority treatment (dialisis, chemotherapy...)
14. Life expectation less than 1 year
15. Benzodiazepines therapeutic uses not for anxiety or insomnio

Primary outcomes:
measure: To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
timeFrame: 10 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Residencia Albertia Moratalaz
city: Madrid
country: Spain
facility: Residencia Amavir Ciudad Lineal
city: Madrid
country: Spain
facility: Residencia Nogales Imperial
city: Madrid
country: Spain
facility: Residencia Nogales Pontones
city: Madrid
country: Spain
facility: Residencia Nogales Puerta de Hierro
city: Majadahonda
country: Spain
facility: Residencia Albertia Valle de la Oliva
city: San Agustín del Guadalix
country: Spain
facility: Residencia Amavir San Agustín
city: Torrejón De Ardoz
country: Spain
facility: Residencia Amavir Torrejón
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Luis Fernando Agüera
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04960995: Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis
Official title: Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Babesiosis, Human
Keywords: Babesiosis
BABESIA
ZOONOSES
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject suffering from severe babesiosis

Brief summary: Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Splenectomized subject
* Subject with severe babesiosis
* Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

- Subject having expressed opposition to participating in the study

Primary outcomes:
measure: A retrospective study describing a case of infection with a new species of Babesia
timeFrame: The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Parasitology and Medical Mycology Department - Strasbourg University Hospitals
Study officials:
affiliation: Parasitology and Medical Mycology Department - Strasbourg University Hospitals
name: Alexander PFAFF, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926795: Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Official title: Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Keywords: toddler's fracture
tibial fracture
children
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.


Eligibility criteria: Inclusion Criteria:

* • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.

Exclusion Criteria:

* • Children with clinical suspicion but lack of radiographic evidence for toddler's fracture

  * Fractures displaced \>2mm
  * Open fractures
  * Pathologic fracture
  * Fractures involving the physis
  * Previous fracture of the ipsilateral extremity
  * Concomitant fracture involving the ipsilateral or contralateral leg
  * Concomitant head injury
  * Non-ambulatory children (i.e., those who have not yet begun to walk)
  * Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)
  * Children who are geographically prohibited from following up in our system
  * Children whose caregivers are not proficient in English
  * Presentation \>7 days from injury
  * Cases considered to be non-accidental trauma

Primary outcomes:
measure: Days to Ambulation
timeFrame: 12 weeks
Secondary outcomes:
measure: Fracture displacement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Michael L Beckish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840995: The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Intracranial Pressure
Keywords: stellate ganglion block
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were scheduled to receive stellate ganglion block at our pain management clinic

Brief summary: The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-70 years of age)
* who were scheduled to receive stellate ganglion block at our pain management clinic

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
* Patients with coagulation disorder
* Patients with severe obesity
* Patients with severe cardiovascular or pulmonary disease
* Patients with cognitive deficits or psychiatric illness

Primary outcomes:
measure: ultrasonographic measurement of optic nerve sheath diameter
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
Clinical trial NCT04473495: The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.
Official title: The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Atrial Fibrillation
Atrial Flutter
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient entering hospitalisation in cardiology department for a cardiology intervention

Brief summary: This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention


Eligibility criteria: Inclusion Criteria:

* patient entering hospitalisation in cardiology department for a cardiology intervention.

Exclusion Criteria:

* protected person.

Primary outcomes:
measure: anxiety
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Central Hospital, Nancy, France
name: Jean-Marc Sellal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869395: Alternative Therapies Prescribed by Pharmacists and Herbalists
Official title: Alternative Therapies Prescribed by Pharmacists and Herbalists for Suspicious Oral Ulcer: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prescription Drug Problems
Keywords: oral potentially malignant lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: herbalist, pharmacist or assistant pharmacist

Brief summary: The cross-sectional study will recruit herbalists and pharmacists at their workplaces (herbal shops and pharmacies); where they will be asked their advice about a patient suffering from a potentially malignant condition.

Detailed description: The cross-sectional study will recruit herbalists and pharmacists at their workplaces (herbal shops and pharmacies); where they will be asked their advice about a patient suffering from a potentially malignant condition.

Based on the standardized simulated patient approach, the cross-sectional study was planned in which an individual interacts with the interviewee according to a previously prepared script.

Eligibility criteria: Inclusion Criteria:

* working as herbalist, pharmacist or assistant pharmacist

Exclusion Criteria:

-

Primary outcomes:
measure: Referral to specialist
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01553695: Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
Official title: Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Touble
deficit
attention
hyperactivity
Touble deficit attention with hyperactivity
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.

As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.

The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.


Eligibility criteria: Inclusion Criteria:

* Authorization to use the data signed social security affiliation

Exclusion Criteria:

* Patient presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\\or psychiatric.

Primary outcomes:
measure: Diagnostic of ADHD using DSM-IV criteria as implemented in the DIVA
timeFrame: Baseline
Secondary outcomes:
measure: score of rating scales (ASRS and WURS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: Pediatric Hospital Lenval
Study officials:
affiliation: CHU de Nice- GCS Lenval
name: Herve CACI, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02700295: Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
Official title: Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: Orthokeratology
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 healthy volunteers

Brief summary: Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion
* Prospect orthokeratology contact lens wearers
* Normal findings in the slit lamp examination, no corneal pathologies

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator
* Current contact lens wearers
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Quantitative changes in the corneal thickness
timeFrame: 1 year
measure: Qualitative changes in the corneal structure
timeFrame: 1 year
Secondary outcomes:
measure: Quantitative changes in the choroidal thickness
timeFrame: 1 year
measure: Qualitative changes in the choroidal structure
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Center for Medical Physics and Biomedical Engineering, Medical University of Vienna
Study officials:
References: