louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05219227: Effect of Laser Acupuncture Augmented by Abdominal Exercises on Abdominal Fat
Official title: Effect of 12 Session of Laser Acupuncture Augmented by Abdominal Exercises on Abdominal Fat in Obese Breast-feeding Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Keywords: obesity
laser acupuncture
abdominal exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of study is to investigate the effect of laser acupuncture and abdominal exercises on abdominal fat in breast feeding women

Detailed description: Forty breast feeding women aged between 20 and 35 years will recruited to the study in the women health department faculty of physical therapy clinic, kafr el sheikh university , Egypt. The evaluation procedures will explained to each participant. participants will be divided into two groups Group A : received laser acupuncture, diet modification and abdominal exercises Group B: received diet modification and abdominal exercises only

Out come measurement BW, BMI, body fat mass (BFM), body fat percent, waist girth, hip girth, and waist-to-hip ratio (WHR) were measured at baseline and the end of treatment. BW, BMI, BFM, and body fat percent were measured using the body composition analyzer (Model Inbody 3.0, Republic of Korea).

Eligibility criteria: Inclusion Criteria:

* All participants are free from any medical problems such as diabetes mellitus, hypertension and thyroid dysfunction.

All participants do not use any hormonal contraceptive method.

Exclusion Criteria:

* Participants will be excluded if they had diabetes, hypertension, cardiac diseases, patients who had endocrine disease or digestive tract disease and patients with neurological or musculoskeletal disorder.

Primary outcomes:
measure: Effect of laser acupuncture and abdominal exercises on Body fat mass
timeFrame: 1 cycle (42 days)
measure: Effect of laser acupuncture and abdominal exercises on Body mass index
timeFrame: 1 cycle (42 days)
measure: Effect of laser acupuncture and abdominal exercises on waist girth, hip girth
timeFrame: 1 cycle (42 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafar Elsheikh Hospital
Study officials:
References:
Clinical trial NCT06445127: Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
Official title: Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SLE (Systemic Lupus)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2024-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialty clinic

Brief summary: This study is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful in patients with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.

Exclusion Criteria:

* Any patient that has undergone a renal transplant.
* Any patient that is receiving renal dialysis

Primary outcomes:
measure: Presence of inflammation
timeFrame: Six months
measure: Presence of fibrosis
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Homa Timlin, MD, MSc, MRCP, CCST
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286427: A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane
Official title: A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epidermolysis Bullosa Dystrophica, Recessive
Ulcer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.

The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.


Eligibility criteria: Inclusion Criteria:

* Age between 2 years and 60
* REBD clinically evident with immunohistological confirmation and / or genetic
* REBD with at least two chronic ulcers (\> 3 months) comparable
* Signing the informed consent of the patient and / or (children) of parents holding parental authority
* Affiliation to a social security scheme (beneficiary or legal)

Exclusion Criteria:

* Epidermoid carcinoma on the target or chronic ulcers
* Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
* Skin bacterial superinfection clinically overt requiring oral antibiotics
* Herpes simplex virus superinfection
* major evolutionary and malnutrition defined as a BMI \<12 or more than 2 variant between screening and randomization OR a serum albumin \<20 g / l or more ranging from 5 g / l between screening and randomization
* major and progressive anemia defined by a Hb \<6 g / liter or variant more than 4 g / l between screening and randomization
* Life expectancy estimated at less than 3 months
* Pregnancy
* Inability to understand or observance of the rules of protocol
* Participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in Mabul

Primary outcomes:
measure: Percentage of ulcerated area re-epithelialised
timeFrame: at 12 weeks from the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
Study officials:
References:
Clinical trial NCT06202027: Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
Official title: Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: FGF23-related Hypophosphataemic Rickets and Osteomalacia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FGF23-related hypophosphataemic rickets and osteomalacia

Brief summary: The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings


Eligibility criteria: Inclusion Criteria:

1. Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
2. Those (or his/her legal guardian) who have agreed in writing to participate in the survey. Children who have obtained a written consent of his/her legal guardian about participation in this survey. In case of pediatric patient, explain sufficiently what you think the patient can understand. In this case, the legal guardian may provide supplementary explanations of the survey.

Exclusion Criteria:

1. Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
2. Patients who intend to use this drug for other purposes
3. Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
4. Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)

Primary outcomes:
measure: safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
timeFrame: 4 weeks after follow up
Secondary outcomes:
measure: Serum Phosphorus Concentration
timeFrame: 24 weeks
measure: 1,25-Dihydroxyvitamin D
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Choi Hyeokjun
Study officials:
References:
Clinical trial NCT00001627: Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes
Official title: Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Diseases
Healthy Volunteers
Keywords: Bone Marrow
Hematopoiesis
DNA
RNA
Viruses
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 154
Sex: ALL
Minimum age (years): 2
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal Volunteers and patients

Brief summary: This study is designed to provide bone marrow and/or blood cells for other research studies. Patients participating in this study will be asked to provide small amounts of medical information and undergo a limited physical examination designed to detect the presence of any obvious blood disease. A blood and bone marrow sample will be obtained to verify that the patient has normal blood cell production.

Researchers plan to obtain bone marrow samples to be used in laboratory studies directed toward understanding the formation of blood cells. Bone marrow samples will be taken from the hip bone of patients and healthy volunteers.

These samples are valuable to many research studies within the Hematology Branch of the National Heart, Lung, and Blood Institute, including studies of normal and abnormal production of blood cells, the viral causes of blood diseases, and the role of the immune system in bone marrow failure and related conditions....

Detailed description: This protocol defines in general terms the purposes for which blood and bone marrow specimens will be collected by members of the Hematology Branch and the conditions under which the sampling will be performed. Samples of blood and bone marrow from healthy volunteers and from patients are indispensable for many research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, and the role of the immune system in marrow failure and related conditions.

Eligibility criteria: * INCLUSION CRITERIA:

Healthy volunteers age greater than or equal to 18 years.

Subjects with hematologic disease age greater than or equal to 2 (for subjects less than 18, blood and bone marrow specimens will be obtained concurrently with clinically indicated sampling).

EXCLUSION CRITERIA:

History of a significant bleeding disorder.

Abnormal host-defense mechanisms.

Primary outcomes:
measure: To provide a readily available supply of samples for blood and bone marrow for in vitro studies in the Hematology Branch laboratories
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Neal S Young, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01462227: Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Official title: The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Type 1 diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-10-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35

Exclusion Criteria:

* pregnancy
* significant diabetes complications
* liver disease, cirrhosis
* cardiac disease
* neurological disorder
* autonomic neuropathy
* kidney disease
* lactose intolerance

Primary outcomes:
measure: Glucose (mg/dL)
timeFrame: End of study (up to 240 minutes)
measure: Glucose Infusion Rate (mg/kg.Min)
timeFrame: End of study (up to 240 minutes)
Secondary outcomes:
measure: Glucagon (pg/mL)
timeFrame: End of study (up to 240 minutes)
measure: Cortisol (ug/dL)
timeFrame: End of study (up to 240 minutes)
measure: Epinephrine (pg/mL)
timeFrame: End of study (up to 240 minutes)
measure: Norepinephrine (pg/mL)
timeFrame: End of study (up to 240 minutes)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03308227: Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients
Official title: Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: Linezolid; PK/PD; Septic shock
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Cttq
First posted: 2017-10-12
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.

Brief summary: The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.

Detailed description: A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T\>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

1. between 18 years old and 75 years old;
2. Admitted to the ICU;
3. Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
4. Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
5. Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
6. Expected to treat with linezolid.

Exclusion Criteria:

1. Unable to take bronchoalveolar lavage via bronchofiberscopy;
2. Allergy, hypersensitivity or a serious reaction to linezolid;
3. Treatment with linezolid during the previous 72 hours;
4. Pregnancy.

Primary outcomes:
measure: The plasma and bronchoalveolar lavage fluid concentrations of linezolid
timeFrame: Baseline, Day 3, Day 7
Secondary outcomes:
measure: Bacterial eradication
timeFrame: Baseline, Day 3, Day 7
Other outcomes:
measure: mortality
timeFrame: 28-mortality and 60-mortality
Locations:
Study officials:
affiliation: Southeast University
name: Yingzi Yingzi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805127: Obstructive Airways Diseases in Emergency Department (OADED) Study
Official title: Obstructive Airways Diseases in Emergency Department (OADED) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Asthma
COPD
Capnography
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2016-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthma and COPD patients

Brief summary: This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

Detailed description: This is a feasibility observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adults asthma and COPD patients (age \>18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.

Eligibility criteria: Inclusion Criteria:

1. Age \>18
2. Ability and willingness to participate the study and sign informed consent form
3. Asthma / COPD patients

Exclusion Criteria:

1. Pregnant women
2. Asthma or COPD patients with FEV1 \> 60%
3. Disability or unwillingness to undergo capnography measurement
4. Cannot be assessed for FEV1
5. Oxygen supply \>5 L/min

Primary outcomes:
measure: Correlation between capnography parameters and severity of asthma
timeFrame: 1/2 hour to 48 hours from enrollment of subjects
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emergency Department, Hadassah University Hospital Mount Scopus
name: Ruth Stalnikowicz, Prof. ; M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01653873: Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis
Official title: to Compare the Efficacy of Parameters From Different Imaging Modality in Predicting the Risk of Future Vertebral Compression Fracture in Osteoporotic Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Fracture
Keywords: fracture
vertebral column
osteoporosis
predictor
vertebroplasty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all the patients received vertebroplasty treatment between 2005.01-2011.12

Brief summary: After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column. With analyzing of the images done right after the 1st vertebroplasty, we can define the parameters from different imaging and they can be predictors of the future fracture.

Detailed description: Vertebroplasty is considered one of the alternatives for the treating of spine compression fracture associated with pain especially for those patients with osteoporosis. However, after vertebroplasty, the compliance of the bone becomes stronger than the adjacent vertebrae that is not treated. So there is always a consideration of future fracture of the adjacent vertebral bodies after vertebroplasty done on certain body. In this study, we try to follow the patients (5 years) to see if the adjacent vertebral bodies are prone to have fracture than the others away from the site of vertebroplasty.Then we try to find out the image biomarkers to predict the future fracture in the vertebral bodies. The should be done with CT scan raw data, analysis with different algorithms.

Inclusion criteria; patients with osteoporosis and receiving vertebroplasty and with secondary fracture occurring in other spine exclusion criteria: No second vertebral body fracture occurred. Primary measurement: the time and location of the 2nd fracture secondary measurement: the imaging biomarkers from CT scan.

Eligibility criteria: Inclusion Criteria:

* All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column.

Exclusion Criteria:

* No image available

Primary outcomes:
measure: fracture
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hon-Man Liu, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ito M, Ikeda K, Nishiguchi M, Shindo H, Uetani M, Hosoi T, Orimo H. Multi-detector row CT imaging of vertebral microstructure for evaluation of fracture risk. J Bone Miner Res. 2005 Oct;20(10):1828-36. doi: 10.1359/JBMR.050610. Epub 2005 Jun 20.