louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04851379: PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)
Official title: PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever of Unknown Origin
Keywords: Fever of Unknown Origin
18F-FDG-PET/CT
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study included all adult patients (age≥18 years) with a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT in the University Hospital of Montpellier (France) between April 2012 and December 2017.

Brief summary: Objective : To explore the diagnostic contribution of the 18F-FDG-PET/CT in a population of patients with classical fever of unknown origin (FUO), to precise its place in the diagnostic decision tree in a real-life setting and to identify factors associated with a diagnostic 18F-FDG-PET/CT.

Methods: All adult patients (age≥18 years) with a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT in the University Hospital of Montpellier (France) between April 2012 and December 2017 were included. True positive 18F-FDG-PET/CT which evidenced a specific disease causing FUO were considered to be contributive.


Eligibility criteria: Inclusion Criteria:

* age≥18 years
* a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT

Exclusion Criteria:

-refusal to participate-

Primary outcomes:
measure: the diagnostic contribution of the 18F-FDG-PET/CT
timeFrame: day 1
Secondary outcomes:
measure: 18F-FDG-PET/CT place in the diagnostic decision tree in a real-life setting
timeFrame: day 1
measure: factors associated with a diagnostic 18F-FDG-PET/CT.
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Camille ROUBILLE, MCUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01657084: Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
Official title: Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient.

Based on the scientific literature on the subject, the study hypothesis is that the fall in body pH will be able to stop and/or prevent epileptic brain activity.


Eligibility criteria: Inclusion Criteria:

* Epilepsy
* 18-80 years

Exclusion Criteria:

-

Primary outcomes:
measure: Length of epileptic seizure (subgroup 1)
timeFrame: Duration of mask treatment during acute seizures: approx. 3 minutes from start of mask treatment until end of seizure
measure: Frequency of epileptic paroxysms (subgroups 2 and 3)
timeFrame: Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG
Secondary outcomes:
measure: Oxygen saturation during mask treatment
timeFrame: Duration of mask treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Dianalund
country: Denmark
facility: The Epilepsy Hospital Filadelfia
Study officials:
affiliation: Aarhus University Hospital
name: Jakob Christensen, M.D., Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182584: Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease
Official title: Application of Digital Infrared Thermal Imaging in Thyroid Disease and Associated Ophthalmopathy and Dermopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graves' Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Graves' disease patients with or without ophthalmopathy and dermopathy

Brief summary: Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.

Detailed description: We will recruited patients of Graves' disease from out patient clinics. We will perform thyroid echo and soft tissue echo first. Then we let patients sit before the thermal camera and take thermal images of eyes necks and tibia. After data collection, we analyse the relation between temperature and laboratory data such as thyroid function and autoimmune profiles.

Eligibility criteria: Inclusion Criteria:

* Graves' disease patients. Healthy people

Exclusion Criteria:

* Pregnancy. \<16 years old or \> 60 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Shyang-Rong Shih
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332384: Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* contraindication to beta-adrenoceptor antagonist or brimonidine therapy

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
References:
Clinical trial NCT05776784: Status of Dental Care Practices in Patients With Hereditary Angioedema
Official title: Status of Dental Care Practices in Patients With Hereditary Angioedema
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angio Edema Hereditary
Keywords: prophylaxis
dental procedures
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with HAE with or without C1 Inhibitor deficiency

Brief summary: Hereditary angioedema (HAE) is a rare genetic disease, it can occur at any age and evolves in flare-ups. These are subcutaneous or submucosal edemas responsible for tightness and pain. All areas can be reached. In addition, all their life, patients have an unpredictable risk of death from asphyxiating angioedema (25% mortality in the absence of specific treatment).

Surgical procedures, endoscopies and dental procedures can trigger laryngeal AE. Thus, the national reference center for angioedema (CREAK) and the latest international consensus1 recommend that all these procedures be preceded by short-term prophylaxis. The reference treatment is the C1 inhibitor 2 concentrate. But to date, there is no prospective study that has demonstrated the effectiveness of this short-term prophylaxis before dental treatment. Only a retrospective study has shown that its implementation made it possible to reduce the risk of crisis by 42% after tooth extraction 3 and that the risk of crisis was greatest within 8 hours following tooth extraction.

The C1 inhibitor concentrate must be administered IVL by a nurse within 6 hours before the procedure and therefore implies, in addition to its high cost (1500 €), an organizational burden for the patient who must plan for the passage of an IDE, the availability of the product and this sometimes for a simple dental treatment.

These constraints have two consequences for dental care: patients avoid going to the dentist to the detriment of their dental health or do not take prophylaxis with the risk of a fatal attack.


Eligibility criteria: Inclusion Criteria:

* Patient with HAE with or without C1 Inhibitor deficiency
* Patient over 18 years old

Exclusion Criteria:

* Patient opposed to the use of their data or refusing to answer the questionnaire
* Adult patients protected by law

Primary outcomes:
measure: the attitude of HAE patients towards dental care
timeFrame: 30 minutes
Secondary outcomes:
measure: Description of crises after dental care
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Grenoble
country: France
facility: chu grenoble alpes CREAK
Study officials:
References:
Clinical trial NCT06707584: Role of MRI in Breast Cancer Subtypes
Official title: Role of MRI in Detection of Breast Cancer Molecular Subtypes in Correlation With Immunohistochemistry Results
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: MRI in Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: any patient with breast cancer

Brief summary: efficacy of MRI in detection of breast cancer molecular subtypes instead of biopsy and immunohistochemistry

Detailed description: 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Patient with breast cancer (malignant breast mass) will do MRI breast and molecular subtypes will be assessed

MRI imaging studies will performed on a 1.5 T scanner , The patient is placed in the prone position with both breasts placed adequately in a double breast coil (four-channel phased array coil), MRI sequences are:

1. Axial T1WI. 2. Axial T2WI. 3. Axial STIR. 4. DCE-MRI with post-processing subtraction images 5- Axial DWI at b value( 0, 400, 800 and 1000 mm\^2 per second) and ADC map will performed 6. MRI spectroscopy MRI acquisition protocol MRI protocols includes

* Axial T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.
* Coronal T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.s
* Short tau inversion recovery - axial: TR=8540 ms, TE=59 ms, TI=170 ms, slice thickness=3.5 mm, and matrix=320×314.4.
* The standard dynamic protocol commenced with a coronal three-dimensional rapid Field echo (thrive) sense non-enhanced T1-weighted sequence.
* A gadolinium containing contrast was administered at a dose of 0.2 ml/ kg by power injection at a speed of 2.0 ml/s and flushed with 20 ml of saline solution at the same rate.
* Dynamic imaging was then done in five consecutive series at 90-s intervals. Standard subtraction images were obtained by subtracting precontract images from the early peak postcontrast image.

Eligibility criteria: Inclusion Criteria:

a. patients with breast cancer confirmed by histopathology,

Exclusion Criteria:

1. breast implants
2. general Contraindication of MRI as claustrophobia

Primary outcomes:
measure: accuracy of MRI in breast cancer subtyping
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00955084: Maintenance Study on the Long Term Safety of XL999
Official title: A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.

The secondary objectives of this study are as follows:

* To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
* To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
* To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.


Eligibility criteria: Inclusion Criteria:

* The subject is currently enrolled in Protocols XL999-001 or XL999-204
* The subject has received XL999 for at least one year prior to enrollment
* Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity

Exclusion Criteria:

* Progressive disease
* Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)

Primary outcomes:
measure: The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
timeFrame: Progressive disease or end of study
Secondary outcomes:
measure: Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration
timeFrame: Progressive disease or end of study
Other outcomes:
Locations:
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland Union State Bank Cancer Center
state: New York
city: San Antonio
country: United States
facility: University of Texas Cancer Center
state: Texas
Study officials:
affiliation: Symphony Evolution, Inc.
name: Charles W. Finn, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05146284: Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)
Official title: A Randomized Open-label Phase 2a Study to Assess PXL770 After 12 Weeks of Treatment in Male Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adrenomyeloneuropathy
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2021-12-06
Enrollment: 0
Sex: MALE
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 randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

Detailed description: A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

There are 3 study periods.

* Screening Visit: within a maximum of 4 weeks prior to the open-label Treatment Period
* Open-label Treatment Period: 12 weeks
* Follow-up Period: 2 weeks after the last intake of the treatment

During the treatment period, VLCFA will be assessed every 4 weeks, to evaluate the kinetics of the effect. NfL will be assessed after 8 and 12 weeks of treatment, and other exploratory biomarkers after 12 weeks of treatment. A follow up period will allow monitoring the subjects' safety as well as the duration of the effect on the 2 main biomarkers (VLCFA and NfL) at 2 and 4 weeks after the drug withdrawal.

Eligibility criteria: Inclusion Criteria:

* Male subjects with either a confirmed diagnosis of AMN by genetic testing (mutation in the ATP binding cassette subfamily D (ABCD1 gene)) or a family history of X-linked adrenoleukodystrophy (ALD) together with an elevation in VLCFA obtained from overnight fasting plasma sample at Screening Visit (V1).
* Age: ≥ 18 to ≤ 65 years at informed consent signature.
* Normal brain magnetic resonance imaging (MRI) or brain MRI showing non-specific abnormalities that can be observed in AMN subjects without signs of cerebral form of ALD (C-ALD). MRI must be performed within 6 months prior to V2. If there is no available brain MRI within this period, a brain MRI must be performed before V2.

Exclusion Criteria:

* Any progressive neurological disease other than AMN.
* Arrested or progressing C-ALD as defined by cerebral lesions (except for non-specific abnormalities that can be observed in AMN subjects).
* Prior receipt of an allogeneic hematopoietic stem cell transplant or gene therapy.

Primary outcomes:
measure: Pharmacokinetic (PK) parameters
timeFrame: 4 week
measure: Pk parameters
timeFrame: 4 week
measure: PK parameters
timeFrame: 4 week
measure: PK parameters
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02639884: Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Official title: Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-28
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.


Eligibility criteria: Inclusion Criteria:

* Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
* Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.

Exclusion Criteria:

* ASA classification higher than III.
* Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
* Inability to obtain any physiological, vital, demographics and real time anaesthesia data
* Subjects who have known intolerance to any of the drugs to be used according to the study protocol
* Subjects deemed not suitable for study at the discretion of the Principal Investigator.

Primary outcomes:
measure: Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected
timeFrame: One visit
measure: Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected
timeFrame: One visit
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: David R Drover, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02921984: Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Official title: Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Salivary Gland Tumors
Head and Neck Cancer
Keywords: Salivary Gland Tumors
Head and Neck Cancer
concurrent chemotherapy
genetic testing
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.


Eligibility criteria: Inclusion Criteria:

1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
4. No evidence of distant metastases
5. No synchronous or concurrent head and neck primary tumors
6. Karnofsky score over 60
7. Adequate organ function including the following:

   1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
   2. Platelets count \>= 100 \* 10\^9/l
   3. Hemoglobin \>= 10 g/dl
   4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
   5. Total bilirubin \<= 1.5 times institutional ULN
   6. Creatinine clearance \>= 50 ml/min
   7. Serum creatine \<= 1 times ULN
8. Signed written informed consent

Exclusion Criteria:

1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Primary outcomes:
measure: Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Disease-free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Guopei Zhu
role: STUDY_CHAIR
References: