louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04451759: Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia
Official title: Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Food intake is a motivated behaviour that consists of seeking, selecting and ingesting nutritional resources from the environment. Its main function is therefore, depending on these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical substrates necessary for the proper functioning and need of the body. Thus, in addition to maintaining the body's fat mass level stable, dietary behaviour is part of the energy homeostasis system and is thus regulated and maintained by the central nervous system.

Although diet regulation involves several brain regions, the way in which these different regions communicate with each other and influence each other to orchestrate appropriate eating behaviour is not yet fully characterized. Among the structures of this network, the hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a crucial role.

The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial small structure in food intake networks in order to better understand the impact of these structural and functional disorders observed in patients with anorexia nervosa and obesity compared to a control population without eating behaviour disorders.


Eligibility criteria: Inclusion Criteria:

* No depression (HADS and BECK scores)
* No contraindication to 7T MRI
* Subject with with social insurance
* Subject who has signed the informed consent

For obese patients

* Body mass index \> 30kg/m2
* Body diameter \< 60cm (compatible with 7T MR scanner tube)

For anorexic patients

* mental anorexia according to DMS-V
* Body mass index \< 17kg/m2

For healthy controls

* 18.5kg/m2\<Body mass index \< 25kg/m2
* no feeding behavioral disturbance (SCOFF and EAT 26)

Exclusion Criteria:

* Pregnant or parturiente woman
* subject with other neurological or neuropsychiatric diseases
* subject with addiction

Primary outcomes:
measure: MRI exploration conducted at 7T
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean Olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05636059: Physiotherapy in Knee Osteoarthritis
Official title: Comparative Effects of Different Physiotherapy Methods on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee function
womac
quality of life
joint mobilization
physiotherapy
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 63
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis symptoms can be managed with non-drug treatments such as patient education, exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce joint inflammation, pain and improve function. Another method is joint mobilization, which can also reduce pain and improve function. Based on this theory, it was hypothesized that cryotherapy will have better effect on pain and the quality of life, whereas joint mobilization will be more effective on knee function. The aim of the study was to compare the effects of different physiotherapy methods on pain, knee joint function and quality of life in individuals with osteoarthritis.

Detailed description: Study included 63 participants with knee osteoarthritis. All subjects were randomly assigned to one of 3 groups: exercise group (n=21), exercise + cryotherapy group (n=21), or exercise + joint mobilization group (n=21). VAS scale was used to assess the pain, quality of life was evaluated with Short Form 36 Health Survey Questionnaire (SF-36) questionnaire, knee ranges of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to evaluate knee osteoarthritis. All the participants received 30 intervention sessions.

Eligibility criteria: Inclusion Criteria:

* stage II of the knee OA;
* affected knee joint;
* pain of at least 3 points on the VAS.

Exclusion Criteria:

* Severe cardiovascular disease;
* Oncological Disorders;
* Allergy to cold / cold intolerance;
* Impaired lower limbs blood circulation;
* Fear of confined spaces;
* Pregnancy or lactation.

Primary outcomes:
measure: Change from baseline Pain at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Quality of Life at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Knee Ranges of Motions at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Knee Muscle Strength at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Knee Health Status at 18 days
timeFrame: Baseline and after 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Vilma Dudonienė, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02804659: Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA
Official title: Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Arteries
Keywords: micro-RNA
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults having to undergo carotid thrombendarteriectomy

Brief summary: Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.


Eligibility criteria: Inclusion Criteria:

* Adults having to undergo carotid thromboendarteriectomy
* social security coverage
* provision of study information
* consent to participation.

Exclusion Criteria:

* Previous carotid artery surgery
* refusal to participate in the study
* or inability to give consent.

Primary outcomes:
measure: expression level of the seven miRNAs of interest
timeFrame: Day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Pierre MAITRIAS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856059: Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI
Official title: Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fabry Disease
Keywords: Fabry disease
Fabry cardiomyopathy
cardiac MRI
CMR
T1 mapping
T2mapping
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Vancouver General Hospital
name: The Cleveland Clinic
name: Icahn School of Medicine at Mount Sinai
name: Mayo Clinic
name: University of Colorado, Denver
name: IRCCS Policlinico S. Donato
name: Alberta Health services
name: Libin Cardiovascular Institute of Alberta
First posted: 2021-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cardiac MRI
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.

Detailed description: Fabry disease is an inherited disorder that affects many organs in the body, including the heart. Men and women are both affected, with average life expectancy reduced by 10-20 years. The heart muscle can become thick and scarred in over half of patients, eventually resulting in heart failure, abnormal rhythm and death. The focus of this study will be on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes.

It is hypothesized that new cardiac MRI techniques called T1 and T2 mapping will improve the ability to detect early abnormalities in the heart. Early detection of cardiac disease may enable a personalized treatment approach, potentially improving patient outcomes. The results of the study will identify which patients might benefit from early initiation of treatment to prevent bad outcomes in the future by using cardiac MRI to identify those at higher risk.

Eligibility criteria: Inclusion Criteria:

* Fabry disease;
* Age ≥ 18 years.

Exclusion Criteria:

* History of myocardial infarction;
* Contraindication to MRI.

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 5 years
Secondary outcomes:
measure: The FAbry STabilization indEX (FASTEX) score
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kate Hanneman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01427959: Tampere Traumatic Head and Brain Injury Study
Official title: Tampere Traumatic Head and Brain Injury Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample consisting of consecutive mild traumatic brain injury patients metting the enrollment criteria.

Brief summary: Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

Detailed description: Aims of the study:

1. To improve clinical assessment of mTBI in the acute phase
2. To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI
3. To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD

Eligibility criteria: Inclusion Criteria:

* WHO's mtbi criteria
* Inhabitant of Pirkanmaa hospital district
* Age between 18 and 60 years

Exclusion Criteria:

* Detrimental alcohol use
* Drug addiction
* Chronic neurological disease
* Earlier brain injury
* Diagnosed psychiatric disease
* Hearing or sight deficiency
* Native language other than finnish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Teemu M. Luoto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528059: Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes
Official title: A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Type 2 Diabetes
Keywords: Diabetes
Gastric cancer
Gastric bypass
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.

Detailed description: Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Type 2 diabetes
2. Diagnosed with gastric cancer

Exclusion Criteria:

1. Type 1 diabetes
2. Unresectable cancers

Primary outcomes:
measure: Glycemic control
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Nutritional status assessment
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: DongFang Hospital
state: Fujian
Study officials:
affiliation: Dongfang Hospital, Xiamen University
name: Yu Wang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416959: Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones
Official title: Prospective Bone Metastases Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm Metastasis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture

Brief summary: The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),

Detailed description: The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Eligibility criteria: Inclusion Criteria:

* Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction

Exclusion Criteria:

* Patients with bone metastases of the spine

Primary outcomes:
measure: Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
timeFrame: 24 months
Secondary outcomes:
measure: Survival in patients undergoing surgery for metastatic bone disease
timeFrame: 24 months
Other outcomes:
measure: Prognostic factor regarding erythrocyte sedimentation rate
timeFrame: 24 months
measure: Prognostic factor regarding C reactive protein
timeFrame: 24 months
measure: Prognostic factor regarding Alkaline phosphatase
timeFrame: 24 months
measure: Prognostic factor regarding white blood cells
timeFrame: 24 months
measure: Prognostic factor regarding hemoglobin
timeFrame: 24 months
measure: Prognostic factor regarding Karnofsky score
timeFrame: 24 months
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Costantino Errani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653159: Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Official title: Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Intrauterine device, contraception, unplanned pregnancy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2008-04-04
Enrollment: 23
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.

Detailed description: Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.

Eligibility criteria: Inclusion Criteria:

Healthy, sexually active females age 14 to 18 who:

* Are interested in long term, reversible contraception
* Have regular menstrual cycles (21-35 days)
* Are not planning a pregnancy within the next 6 months

Exclusion Criteria:

Sexually active females age over the age of 18 or who:

* Are not interested in long term, reversible contraception
* Do not have regular menstrual cycles (21-35 days)
* Are planning a pregnancy within the next 6 months

Primary outcomes:
measure: Retention Rate
timeFrame: 6 months
Secondary outcomes:
measure: Heavy Bleeding Rates
timeFrame: 6 months
measure: Pregnancy Rates
timeFrame: 6 months
measure: Expulsion Rates
timeFrame: 6 months
measure: Device Satisfaction Rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: The University of Chicago Medicine
name: Melissa Gilliam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01188759: Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
Official title: A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Aspergillosis
Invasive Pulmonary Aspergillosis
Neuroaspergillosis
Keywords: Aspergillosis
Combination Therapy
Voriconazole
Anidulafungin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of proven, probable, or possible invasive aspergillosis.
* Hematologic malignancy or allogeneic hematopoetic stem cell transplant.

Exclusion Criteria:

* Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
* Chronic invasive aspergillosis.
* Receipt of antifungal treatment for more than 96 hours.
* Severe liver dysfunction.

Primary outcomes:
measure: Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of all-cause mortality at 6 weeks
timeFrame: 6 weeks
measure: Rate of all-cause mortality at EOT
timeFrame: 12 weeks
measure: Global response to therapy at 6 weeks
timeFrame: 6 weeks
measure: Global response to therapy at EOT
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: