louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00737919: The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Official title: The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Cholesterol
Plant sterols
Atherosclerotic carotid plaques
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2008-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.

Detailed description: This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols.

This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.

Eligibility criteria: Inclusion Criteria:

* Asymptomatic tight carotid plaques
* Age 40-80

Exclusion Criteria:

* No

Primary outcomes:
measure: Sterols in serum and carotid plaques at the operation
timeFrame: at operation and one month after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital
Study officials:
affiliation: Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki
name: Tatu A. Miettinen, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland
name: Helena Gylling, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland
name: Markku J Nissinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475119: Effect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea
Official title: Effect of High Flow Nasal Cannula (HFNC) Versus Continues Positive Airway Pressure (CPAP) in Adults With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The participants whom undergo Polysomnography study (Sleep study) and are found to have mild, moderate or severe Obstructive Sleep Apnea (OSA) will have two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

Detailed description: The participants undergo three nights in the Sleep Lab. In their first night they perpetrate Polysomnography study (Sleep study) and then classifies to have mild, moderate or severe Obstructive Sleep Apnea (OSA) or not. Those who are diagnosed with OSA, will undergo two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

Eligibility criteria: Inclusion Criteria:

* Adults patient aging above 18 years
* Diagnosed with Obstructive Sleep Apnea (OSA) based on Polysomnography (PSG) ranging from mild to severe i.e. more than 5

Exclusion Criteria:

* Patients with hypoventilation syndrome
* Patients with chronic obstructive pulmonary disease
* Patients who have unstable hemodynamic state, who experienced intolerance to HFNC or CPAP
* Patients who are pregnant
* Patients recently underwent surgery

Primary outcomes:
measure: Apnea/Hypopnea Index count using High Flow Nasal Cannula oxygen device and Continuous Positive Pressure Airway device on patients with Obstructive Sleep Apnea
timeFrame: two nights
measure: Sleep architecture while using High Flow Nasal Cannula oxygen device
timeFrame: two nights
measure: Tolerance and acceptability of High Flow Nasal Cannula by patients compared to the standard Continuous Positive Airway Pressure
timeFrame: two nights
Secondary outcomes:
measure: Changes in sleep structure compared to the diagnostic night
timeFrame: two night
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
state: Western
Study officials:
affiliation: Teaching Assistant at King Abdulaziz University
name: Siraj O Wali, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02511119: Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, New York
First posted: 2015-07-29
Enrollment: 300
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: The patients were followed up in the Pigmented Lesions Unit at Reina Sofia University Hospital. In a subgroup of 200 patients, the investigators will analyze the dermoscopic imagines of melanocytic nevus, atypical nevus and melanomas to seek common patterns using artificial intelligence methods. With the patterns obtained, the investigators will build a robust model to classify population with the risk of developing melanoma. In this model the sociodemographic, clinical and genetic data will be used to increase the accuracy of the obtained model. In a second phase, in a subgroup of 100 different patients, the degree of accuracy of the predictive model will be evaluated.

Brief summary: The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age;
* Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi);
* All nevi for which there is at least one dermatoscopy registry will be included.

Exclusion Criteria:

* not enough data in the patient clinical history;
* located lesions on the face, scalp, mucous membrane or on acral área;
* nodular or metastatic melanoma diagnosis
* type V or VI of Fitzpatrick phototyping scale

Primary outcomes:
measure: Number of participants with Melanoma
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04624919: Comparison of Fatigue in Varying Hot Environments
Official title: Comparison of Fatigue in Varying Hot Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, counterbalanced crossover design
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.

Detailed description: After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.

Eligibility criteria: Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* Current tobacco use or regular use within the last 2 years
* Current musculoskeletal injury
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
* Currently pregnant or breastfeeding, or planning to become pregnant during the study
* Inability to follow the rules of the protocols or understand the consent form
* Contraindications of consuming a core temperature monitoring pill

Primary outcomes:
measure: Smoothness of movement
timeFrame: 90 minutes
measure: Energy Expenditure
timeFrame: 90 minutes
Secondary outcomes:
measure: Perceptual fatigue
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Exercise in Special Environments
state: New York
Study officials:
References:
Clinical trial NCT00773019: SynchroMed II Post-Approval Study
Official title: SynchroMed II Programmable Drug Infusion System Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Spasticity
Chronic Pain
Keywords: infusion pump
implantable
performance
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 84
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: Subjects planning to receive a new or replacement drug pump.

Brief summary: This FDA Condition of Approval study will include up to 100 subjects at up to 13 US centers. Subjects are selected from those evaluated and planning to receive a SynchroMed II drug infusion system for treatment of severe spasticity or chronic pain. Subjects must return for refill visits at 1, 6, and 12 months. In addition, subjects return for any other medically necessary refills. Information is collected on all refills and adverse events.


Eligibility criteria: Inclusion Criteria:

* Have chronic intractable severe spasticity or chronic pain requiring intrathecal delivery of medication
* Have undergone a pre-implant assessment and determined to be an appropriate candidate for implantation of an infusion system
* Be geographically stable and willing to return to the study center for follow-up visits
* Subject, or subject's legal representative, has signed informed consent form prior to any study-related procedures
* Age is at least 18 years of age at time of enrollment

Exclusion Criteria:

* Have a condition in which the pump cannot be implanted 2.5 cm or less from the surface of the skin
* Have an ongoing infection prior to implant
* Have insufficient body mass to accept the pump bulk and weight
* Are unable or unwilling to adhere to the study protocol
* Have an estimated life expectancy of less than twelve months

Primary outcomes:
measure: Compare the observed volume of drug dispensed by the pump to the programmer's calculated volume of drug dispensed
timeFrame: six months
Secondary outcomes:
measure: Characterize adverse events experienced with the drug infusion system
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00509119: ICP Waveform Analysis in Stroke Patients
Official title: Retrospective ICP Waveform Analysis in Stroke Patients Followed Prospectively
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Keywords: apoplexia
Intracranial and intraarterial pressure curves in acute apoplectic patients
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ICH

Brief summary: This is a study on how acute clinical state and final clinical outcome in patients with stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform parameters recorded during intensive care management.

Detailed description: Aim of study:

* Prospectively collect clinical and radiological data as well as management data.
* Perform retrospective analysis of ICP/ABP recordings (mean ICP, mean ICP wave amplitude, mean ABP, mean ABP wave amplitude, CPP)
* Relate the prospectively collected data with results of retrospective pressure analysis.

Eligibility criteria: Inclusion Criteria:

* Acute apoplexy

Exclusion Criteria:

* Subarachnoidal bleeding

Primary outcomes:
measure: Clinical outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet - Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Gunnar Bentsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05943119: Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
Official title: Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tumor, Solid
Keywords: IMRT
sinus
nasal
Mucosal toxicity
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 52
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 patient is randomized to one of the following groups:

* Experimental group: Radiotherapy in painting dose on histoscannographic mapping
* Control group: standard pan-sinus radiotherapy


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age
* Patient with histologically confirmed nasosinus carcinoma
* Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy
* Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)
* Signature of informed consent prior to any specific study procedure
* Subject affiliated to a social security system

Exclusion Criteria:

* Patient with not operated in place tumor
* Patient with distant metastases
* Patient treated with neoadjuvant chemotherapy
* Delay between surgery and radiotherapy greater than 8 weeks
* Other histologies (melanoma, sarcoma, lymphoma, etc.)
* Pregnant or breast-feeding woman or absence of contraception during genital activity
* History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.
* Simultaneous participation in another therapeutic clinical trial
* Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.
* Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons

Primary outcomes:
measure: Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
timeFrame: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
References:
Clinical trial NCT00539019: Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Burns
Keywords: nutrition assessment
pediatric
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: burned, pediatrics pooled from inpatient acute population

Brief summary: The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.


Eligibility criteria: Inclusion Criteria:

* \>25% burn surface area
* Wounds present as 95% healed
* Admitted to Shriners Hospital Cincinnati within 7 days of injury

Exclusion Criteria:

* \<5years old
* \<25% burn injury
* admitted greater than 7 days postburn

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
affiliation: Shriners Hospital for Children, Cincinnati, Ohio
name: Theresa M Mayes, RD,LD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929719: Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-11
Enrollment: 1134
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic equivalence and safety study

Detailed description: To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD).

To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment.

To compare the safety of Test, Reference and Placebo treatments.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Primary outcomes:
measure: Change in inflammatory lesion count
timeFrame: baseline to week 12 (study day 84)
measure: Change in non-inflammatory lesion count
timeFrame: baseline to week 12 (study day 84)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
References:
Clinical trial NCT03348319: Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?
Official title: The Pancreas and the Bilio-pancreatic Junction: Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreas
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive cadavers donated to the Department of Anatomy, Faculty of Medicine and University Hospital, Champagne-Ardenne University

Brief summary: Limited pancreatic resections are increasingly performed, but the rate of postoperative fistula is higher than after classical resections. Pancreatic segmentation, anatomically and radiologically identifiable, may theoretically help the surgeon removing selected anatomical portions with their own segmental pancreatic duct and thus might decrease the postoperative fistula rate. Current pancreatic segmentation theories do not enable defining anatomical-surgical pancreatic segments. To our knowledge, no study has tried to describe pancreatic segmentation from the divisions of the pancreatic ducts to date. Hence, we hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts, using extensive reconstructions of pancreatic duct using micro-scanner on injected human pancreas.

Detailed description: * In a first step, the injection technique will be developed (dilution, stability, hardening of the contrast mixture).
* In a second step, we will inject the mixture in human pancreas: into the duct tree, the vein and arteries. After hardening, the human pancreas will be removed from cadavers following the organ donation technique. The anatomic specimens will be scanned in the laboratory UMR CNRS 7369 MEDyC, Reims (Pr X. MAQUART, Dr J. DEVY).
* The images obtained (Dicom format) are very big in term of file size. Analysis of the images will be performed using a supercomputer of the laboratory CReSTIC - ROMEO EA 3804, Reims (Dr A. RENARD, Pr M. KRAJEKI). 3D reconstructions will be performed.

Eligibility criteria: inclusion criteria :

* All consecutive cadavers donated to the Department of Anatomy, Faculty of Medicine and University Hospital, Champagne-Ardenne University for anatomical education and research will be studied. These cadavers will be studied following all the ethical rules of work on cadaver material in our institution.

exclusion criteria :

* Cadavers not usable due to learning necessity, to failure of conservation, dissection difficulties.

Primary outcomes:
measure: Size of the ducts
timeFrame: baseline
measure: Number of branching
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: