louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02201134: SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Official title: SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Therapeutic Hypothermia
Keywords: Cardiac arrest
Therapeutic hypothermia
Sevoflurane
Sedation
Patient resuscitated from cardiac arrest
Requiring sedation
Adult patients
Patient covered by french health care system
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
name: Hopital Gabriel Montpied
First posted: 2014-07-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.

Detailed description: Prospective clinical study in ICU with ventilated patients sedated with sevoflurane using the Mirus® and Anaconda® , establishing the feasibility of an initial sedation of patients resuscitated from cardiac arrest and treated with therapeutic hypothermia.

Eligibility criteria: Inclusion Criteria:

* -Adult patients ventilated requiring therapeutic hypothermia in ICU
* Stable respiratory and hemodynamic conditions
* Epinephrine and norepinephrine infusion rate \< 1,5 g/kg/min
* Consent of patients or family
* Arterial line
* Patients resuscitated after cardiac arrest
* No Flow \< 10 min
* Low Flow \< 20 min
* Neutropenia \< 1 G/L
* Post traumatic cardiac arrest
* Contraindication of halogenated anesthesics
* Extra corporeal life support or intra aortic balloon pump

Exclusion Criteria:

* -Pregnant woman
* Hemodynamic instability
* Brain death defined by the disappearance of brain stem reflexes

Primary outcomes:
measure: Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients
timeFrame: at day 1
Secondary outcomes:
measure: Determination of neurological prognostic of patients at ICU and hospital discharge
timeFrame: at day 1
measure: Determination of systemic complications and organ failures during hospitalisation
timeFrame: at day 1
measure: Evaluation of systemic inflammation and evolution with cytokines
timeFrame: at day 1
measure: Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05569434: 68Ga-P16-093 PET/CT Imaging in Glioma Patients
Official title: 68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Glioma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including glioma. This makes it a potentially imaging target for the detection and grading of gliomas. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with MRI in the same group of glioma patients.

Detailed description: Glioma is the most common primary malignant brain tumor which can be divided into four grades according to different histopathological and molecular biological characteristics.Among them, glioblastoma is one of the most common types of glioma in adults (about 55%). It belongs to WHO Grade IV high-grade glioma, with a high recurrence rate, poor prognosis, and a 5-year survival rate of less than 10%. Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as glioma. Therefore, PSMA may be an ideal target for the diagnosis of glioma. 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in the same group of glioma patients, compared with MRI.

Eligibility criteria: Inclusion Criteria:

* glioma patients highly suggested by MRI or histologically confirmed;
* 68Ga-P16-093 PET/CT and MRI within two weeks;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: standardized uptake value (SUV) of tumor
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012934: Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: MylanPharma
Sponsor class: UNKNOWN
First posted: 2009-11-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: urine collection up to 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Insitute Ltd.
state: North Dakota
Study officials:
References:
Clinical trial NCT05695534: Use of VR in Patients' Education Prior to Implantation of PPM
Official title: Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker DDD
Keywords: Virtual Reality
Education
Lead sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.

Detailed description: The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior to implantation of a permanent pacemaker. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help patients to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures patients need to take after the procedure.

Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.

Eligibility criteria: Inclusion Criteria: Patient needs to fullfill indication criteria for a pacemaker implantation -

Exclusion Criteria: Visual impairment

-

Primary outcomes:
measure: Quality of VR augmented eduacation assessed by a questionaire
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01735734: Assessing the Effects of Air-cooling on Capillary Malformations
Official title: An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Capillary Malformation
Laser
Skin Cooling
Keywords: Skin disease
Capillary Malformation
Laser therapy
Lead sponsor: National Health Service, United Kingdom
Sponsor class: OTHER_GOV
First posted: 2012-11-28
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Capillary Malformation identified through our department database

Brief summary: The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

Detailed description: Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.

Eligibility criteria: Inclusion Criteria:

* Adult more than 16 years of age
* Patient diagnosed with Capillary Malformation

Exclusion Criteria:

* Patients less than 16 years of age

Primary outcomes:
measure: To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Irving Ling, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Greater Glasgow and Clyde
name: Adam Gilmour, MBChB, MRCS (Ed)
role: STUDY_CHAIR
affiliation: NHS Greater Glasgow and Clyde
name: Iain Mackay, MBChb, MRCS, FRCS (plast)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00310934: A Stepwise Strategy Utilizing Buprenorphine and Methadone
Official title: Graded Strategy for Pharmacological Treatment of Heroin Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heroin Dependence
Keywords: heroin dependence
methadone
buprenorphine
contingency management
relapse prevention
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish National Drug Policy Coordinator
name: Region Stockholm
name: Schering-Plough
First posted: 2006-04-05
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

Detailed description: The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* Heroin dependence according to DSM IV \> 1year
* Age \> 20 years
* Acceptance of the stated treatment principles.

Exclusion Criteria:

* Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
* Other clinically significant psychiatric illness unless stable under treatment
* Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
* Other clinically significant medical condition unless stable under treatment
* Treatment with anti-seizure drugs or disulfiram
* Pregnancy or intent to become pregnant within the next year
* Ongoing nursing
* Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.

Primary outcomes:
measure: Retention in treatment
Secondary outcomes:
measure: Proportion urine samples free of illicit drugs
measure: Problem severity as measured by Addiction Severity Index
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Clinical Neuroscience, Karolinska Inst
Study officials:
affiliation: Karolinska Institute, Stockholm
name: Markus Heilig, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02881034: Ribavirin Bioavailability After Telaprevir Exposure
Official title: Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Anemia
Antiviral Agents
Glomerular Filtration Rate
Hepatitis C
Ribavirin
Telaprevir
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir

Brief summary: Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatitis C virus infection
* Previous non-response to pegylated-interferon/ribavirin therapy
* Re-treatment with pegylated-interferon/ribavirin and telaprevir

Exclusion Criteria:

* Decompensated liver cirrhosis

Primary outcomes:
measure: Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
timeFrame: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Secondary outcomes:
measure: Change in renal function between baseline and week 4 of triple therapy
timeFrame: Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
measure: Ribavirin plasma trough concentration at week 8 of therapy
timeFrame: at the later phase of therapy (Week 8 ± 2 weeks)
measure: Ribavirin plasma trough concentration after telaprevir withdrawal
timeFrame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
measure: Renal function at week 8 of therapy
timeFrame: at the later phase of therapy (Week 8 ± 2 weeks)
measure: Renal function after telaprevir withdrawal
timeFrame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT05126134: Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
Official title: Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Dysphoria, Adolescent
Keywords: mental disorders
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adolescents receiving follow-up in a specialized consultation on gender dysphoria

Brief summary: The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade. However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France. The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents. This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life. A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers. This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process. transition process.


Eligibility criteria: Inclusion Criteria:

* Be between 12 and 18 years old
* Be followed up at the gender consultation of the Toulouse University Hospital

Exclusion Criteria:

* Have not yet completed the first consultation on gender issues at the time of selection.
* Have only one last appointment with the gender consultation at the time of selection

Primary outcomes:
measure: list of diagnoses of mental disorders
timeFrame: enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Sophie Çabal-Berthoumieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675934: Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Official title: Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonic Neoplasms
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.

Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.

Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.


Eligibility criteria: Inclusion Criteria:

* Adult patients over the age 18 undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Age less than 18
* Pregnant
* History of ulcerative colitis or Crohn's disease
* History of polyposis syndromes
* History of colon resection
* Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)

Primary outcomes:
measure: Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.
timeFrame: After 50% and 100% of patient enrollment is complete.
Secondary outcomes:
measure: Adenoma detection rate in forward and retroflexed views.
timeFrame: After 50% and 100% of patient enrollment is complete.
measure: Reasons for failure of retroflexion.
timeFrame: After 50% and 100% of patient enrollment is complete.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Surgery Center
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Young Oh, MD
role: PRINCIPAL_INVESTIGATOR
References: