louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06882200: A Combined Mindfulness-diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study
Official title: Benefit of the Bathysmed® Diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Overweight
Keywords: obesity
mindfulness
diving
exercise
Lead sponsor: BATHYSMED
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 63
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a combined minfulness-diving program has an impact on emotional eating in adults with obesity. The main questions it aims to answer are:

Does the BathysMed protocol have an impact on emotional eating after the 2 months diving protocol? Researchers will compare the diving program to a control group of adult patients with obesity.

Participants will be asked to participate in the combined mindfulness-diving protocol for 2 months, and complete the questionnaires at baseline, 2, 5, and 8 months follow up.

Detailed description: This unblinded randomized controlled trial is performed in the community setting, Montpellier, France. Adults with a BMI \> 30kg/m2 were randomly assigned (1:1) to a Bathysmed® 2-month program (intervention group) therapeutic scuba-diving protocol with mindfulness exercises plus standard care, or stand-alone standard care including dietary and psychological support (control group). The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 2-months as intention to treat.

Eligibility criteria: Inclusion Criteria:

* patients with obesity (Body Mass Index BMI \> 30kg/m2),
* adults over the age of 18 able to provide written consent
* affiliated to public medical insurance.

Exclusion Criteria:

* BMI \> 45 kg/m2,
* older than 60 years,
* unable to walk,
* known psychiatric pathology apart from anxiety and depression,
* intellectual deficit,
* routinely practising meditation,
* a known contra-indication to scuba-diving
* known past medical history of cardiac problems.

Primary outcomes:
measure: DEBQ-EE
timeFrame: 2 months
Secondary outcomes:
measure: DEBQ-EE at 5 and 8 months follow up
timeFrame: 5 and 8 months follow up
measure: DEBQ-RE
timeFrame: 2, 5 and 8 months follow up
measure: DEBQ-ExtE
timeFrame: 2, 5 and 8 months follow up
measure: WSSQ
timeFrame: 2, 5 and 8 months follow up
measure: EQVOD scale
timeFrame: 2, 5 and 8 months follow up
measure: PSS Score
timeFrame: 2, 5 and 8 months follow up
measure: Weight (kg)
timeFrame: 2, 5 and 8 months follow up
measure: BMI kg/m2
timeFrame: 2, 5 and 8 months follow up
measure: Waist circumference
timeFrame: 2, 5 and 8 months follow up
Other outcomes:
Locations:
city: Montpellier
country: France
facility: BathysMed
Study officials:
References:
Clinical trial NCT01496300: Benefit of Orthopedic Navigation in the ARThroplasty of the Hip
Official title: Randomised Controlled Double-blind Monocenter Therapy Study Validating the Benefit From Information Provided by Image Free Navigation System on the Precision of the Placement of Acetabular Component in Patients Undergoing Primary THA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Arthritis, Rheumatoid
Femur Head Necrosis
Keywords: Navigation OrthoPilot Hip TEP THA
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 89
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.


Eligibility criteria: Inclusion Criteria:

* Indication for primary cementless total hip endoprosthesis implantation with Bicontact stem and Plasmacup
* Diagnoses: primary or secondary coxarthrosis, rheumatoid arthritis, femoral head necrosis
* Age ≥ 50 Years
* ASA score \<4
* Patient signed the informed consent

Exclusion Criteria:

* Excessive damage to the hip joint (e.g. dysplasia)
* Severe deformities of the pelvis, femoral bone or knee
* Unfeasibility of landmark palpation (e.g. due to adiposity)
* Acute or chronic infection
* Pregnancy
* Patients not available for follow-up-examination at the center
* Patients exceeding 10 mSv effective radiation dose because of previous scientific or clinical exposition during the past 10 years

Primary outcomes:
measure: Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.
timeFrame: 3 months
Other outcomes:
Locations:
city: Bünde
country: Germany
facility: Lukas-Krankenhaus
Study officials:
affiliation: Lukas Krankenhaus Bünde
name: Hartmuth Kiefer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05536700: Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma
Official title: Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: mass spectrometry
serum immunoglobulin
minimal residual disease
MRD
EasyM
M protein
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Shanghai Kuaixu Biotechnology Co., Ltd
First posted: 2022-09-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with MM.

Brief summary: The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (\> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.


Eligibility criteria: Inclusion Criteria:

Subjects with available baseline and sequential serum samples.

Exclusion Criteria:

Subjects without baseline and sequential serum samples.

Primary outcomes:
measure: Quantitative measurement of M protein
timeFrame: From June 6, 2022 to December 31, 2022
Secondary outcomes:
measure: sequence detection of M protein
timeFrame: From December 31, 2021 to May 31, 2022
Other outcomes:
Locations:
city: Tianjin
country: China
facility: InsituteHBDH
Study officials:
affiliation: Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
name: InstituteHBDH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02697500: Pre-analytical Sample Handling Conditions and Their Effects on the Human Serum Metabolome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2016-03-03
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women will be recruited from the area surrounding the BHNRC. There are several thousand government and privately employed workers located within a 10-mile radius of the BHNRC and several residential communities from which a cohort of volunteers will be recruited. The population includes an ethnically diverse group of subjects.

Brief summary: This study evaluates how blood serum handling conditions can affect the concentrations of \~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Detailed description: Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Eligibility criteria: Inclusion Criteria:

* Age 20 to 65 years at beginning of study.
* BMI between 18.5 and 35.0 kg/m2.

Exclusion Criteria:

* Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
* Unable or unwilling to give informed consent or communicate with study staff.
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Primary outcomes:
measure: Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight.
timeFrame: on day one
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT01649700: Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Official title: Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: The Sequelae Caused by Severe Brain Injury
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.


Eligibility criteria: Inclusion Criteria:

* Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
* Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
* Subject's modified Rankin scale (mRS) grades IV\~V.
* Ages between 20\~40 years.
* Estimated life expectancy must be greater than 2 months.
* Signed informed consent from the subject.

Exclusion Criteria:

* Pregnancy test positive.
* Subject infected with hepatitis C, HIV or syphilis.
* Subject not suitable for liposuction surgery.
* Subject not eligible for PET or MRI.
* Subject enrolled in any other cell therapy studies within the past 30 days.
* Subject deemed to be not suitable for the study by the investigator.

Primary outcomes:
measure: Safety evaluation
timeFrame: 16 months
Secondary outcomes:
measure: Positron emission tomography
timeFrame: 13 months
measure: Magnetic Resonance Imaging
timeFrame: 16 months
measure: Electroencephalogram
timeFrame: 16 months
measure: Neuropsychological assessment
timeFrame: 16 months
measure: Electrodiagnostic Testing
timeFrame: 16 months
measure: Assessment of language and swallowing functions
timeFrame: 16 months
measure: Measure of the severity of disability
timeFrame: 16 months
measure: Assessment of spasticity and strength
timeFrame: 16 months
measure: Assessment of brain motor control
timeFrame: 16 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT00005900: Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: I Cell Disease
Fucosidosis
Globoid Cell Leukodystrophy
Adrenoleukodystrophy
Mannosidosis
Niemann-Pick Disease
Pulmonary Complications
Mucopolysaccharidosis I
Mucopolysaccharidosis VI
Metachromatic Leukodystrophy
Gaucher's Disease
Wolman Disease
Keywords: Gaucher's disease
I cell disease
Niemann-Pick disease
Wolman disease
adrenoleukodystrophy
disease-related problem/condition
fucosidosis
genetic diseases and dysmorphic syndromes
globoid cell leukodystrophy
inborn errors of metabolism
mannosidosis
metachromatic leukodystrophy
mucopolysaccharidosis
mucopolysaccharidosis I
mucopolysaccharidosis VI
oncologic disorders
pulmonary complications
rare disease
sphingolipidoses
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications.

II. Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT.

III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been no pulmonary complications.

Detailed description: PROTOCOL OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage (BAL) prior to allogeneic hematopoietic stem cell transplantation (HSCT). ELISA assays for cytokines are performed. Patients are followed post-HSCT for the development of transplant related pulmonary complications. A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop. Cytokine assays are repeated.

Eligibility criteria: * Diagnosis of an inborn error of metabolism eligible for allogeneic hematopoietic stem cell transplantation on protocol UMN-MT-1995-01

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview University Medical Center
state: Minnesota
Study officials:
affiliation: Fairview University Medical Center
name: K. Scott Baker
role: STUDY_CHAIR
References:
Clinical trial NCT03640052: Pharmacological Activation of HMN for OSA
Official title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility criteria: Inclusion Criteria:

* AHI \> 10 events/h during NREM supine sleep

Exclusion Criteria:

* Any medical condition other than well controlled hypertension and mild diabetes.
* Any medication known to influence breathing, sleep/arousal, or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to any of the medications tested in the protocol.
* History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
* For women: Pregnancy.
* Pulmonary hypertension
* Severe OSA with a mean SaO2 lower than 88%

Primary outcomes:
measure: Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)
timeFrame: 1 night
Secondary outcomes:
measure: Collapsibility of the Upper Airway: VActive (L/Min)
timeFrame: 1 night
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Sleep Disorders Research Program Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01856452: Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer
Official title: Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Sentinel lymph node
multimodal
breast cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-05-17
Enrollment: 86
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB
2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Detailed description: Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Eligibility criteria: Inclusion Criteria:

* clinically lymph node negative breast cancer patients
* consented patients with more than 20 years

Exclusion Criteria:

* history of breast cancer
* locally advanced breast cancer and metastatic breast cancer
* proven axillary lymph node metastasis
* history of axillary excisional or incisional biopsy, or dissection
* history of neoadjuvant chemotherapy
* pregnancy
* non-consented patients
* younger than 20 years old

Primary outcomes:
measure: Time to sentinel lymph node biopsy
timeFrame: up to 6 months
Secondary outcomes:
measure: Identification rate of sentinel lymph node biopsy
timeFrame: 13 months
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: So-Youn Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06453252: Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study
Official title: Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke, Ischemic
Intracranial Atherosclerosis
Posterior Circulation Brain Infarction
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2024-06-11
Enrollment: 150
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: The cohort is divided into 2 groups;

1. ICAD-related stroke made when a smooth-bordered lesions leading to delayed perfusion on conventional-angiography (without competing stroke etiology) or when irregular-surfaced lesions involving the target vessel during mechanical thrombectomy were unveiled (with or without competing stroke etiology).
2. Non-ICAD cases (controls) includes patients with posterior circulation stroke attributed to stroke etiologies other than ICAD.

Brief summary: Early identification of intracranial atherosclerotic disease (ICAD) may impact the management of patients undergoing mechanical thrombectomy (MT). The aim of the study is to develop and validate a scoring system for pre-thrombectomy diagnosis of ICAD in posterior circulation large vessel/distal medium vessel occlusion strokes (LVOs/DMVOs).


Eligibility criteria: Inclusion Criteria:

1. Adult ≥18 years
2. Patient with posterior circulation strokes who underwent mechanical thrombectomy.

Exclusion Criteria:

1. Patients with anterior circulation stroke.
2. Patients with intracranial hemorrhage
3. Patients without baseline radiological data.
4. Extracranial large vessel atherosclerosis related strokes.

Primary outcomes:
measure: Post-procedural outcomes included any intracranial hemorrhage, symptomatic ICH (sICH)
timeFrame: June 1st, 2025
Secondary outcomes:
measure: 90 day modified Rankin scale (mRS)
timeFrame: June 1st, 2025
measure: 90 day mortality
timeFrame: June 1st, 2025
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus stroke and neuroscience center, Grady Memorial Hospital
state: Georgia
city: Sohag
country: Egypt
facility: Sohag university hospitals
Study officials:
References: