louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01934478: Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer
Official title: Study on Human Epidermal Growth Factor 2 (Her2) Expression Changes in Human Breast Cancer After Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Keywords: Breast
Cancer
Human Epidermal Growth Factor 2 (Her2)
irradiation
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study population is among advanced Chinese breast cancer patient.

Brief summary: Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or up. The propose of this study is to reveal the irradiation result on Her2 expression in human breast cancer.


Eligibility criteria: Inclusion Criteria:

* histological confirmed advanced breast cancer
* cancer sample can be obtained by fine needle biopsy
* IHC and FISH confirmed Her2 negative
* radiotherapy indication for local residual cancer

Exclusion Criteria:

* no radiotherapy indication
* patient refuse

Primary outcomes:
measure: Her2 changes during radiotherapy
timeFrame: every week up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital, Qingdao Cancer Hospital
state: Shandong
Study officials:
affiliation: Qingdao Health Bereau
name: ketao lan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03396978: The Influence of Gonadal Hormone Suppression on Adipocyte Lineage and the Microbiome
Official title: The Influence of Gonadal Hormone Suppression on Adipocyte Lineage and the Microbiome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adipose Tissue
Microbiome
Menopause
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research study plans to learn more about the role of female sex hormones on adipose tissue (or fat) and the gut microbiome (or the organisms that are in your digestive tract). The rationale for this study is that the rate at which women gain fat (especially in the stomach region) increases after menopause. It is thought to be due to the loss of estrogen because post-menopausal women who take estrogen gain less weight than those who do not take estrogen. Gut bacteria process estrogen and help determine the types of estrogen that circulate in the body. These bacteria can be changed with lifestyle factors such as diet, and may therefore, also affect the risk of diseases that are more common in women after menopause i.e., cardiovascular disease and cancer. In this study the investigators will obtain fat biopsies before and after 6 months of ovarian hormone suppression to measure how the fat cells change with the loss of female sex hormones (e.g., medical menopause). The investigators will also obtain stool and urine samples before and every month during the study to measure changes in the microbiome.


Eligibility criteria: Inclusion Criteria:

* Enrollment into the parent protocol (COMIRB 16-1479 - The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT; PI - Edward Melanson, PhD)
* Participation in GnRHag intervention

Exclusion Criteria:

* Known allergy to lidocaine or other numbing medication
* Uncontrolled bleeding disorder or inability to withhold aspirin/NSAIDs or other blood thinning medications for 7 days prior to biopsy procedure.

Primary outcomes:
measure: Accumulation of Myeloid Cells
timeFrame: 8 months after enrollment of last participant
measure: Progenitor proliferation and adipogenic potential
timeFrame: 1 year after completion of last participant
measure: Gut microbial diversity
timeFrame: 1 year after completion of last participant
Secondary outcomes:
measure: In Vitro Metabolic Phenotyping
timeFrame: 2 years after completion of last participant
measure: β-glucuronidase activity
timeFrame: 2 years after completion of last participant
measure: Estrogen parent: metabolite ratios
timeFrame: 2 years after completion of last participant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kathleen M Gavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05318378: Inverting Grayscale Improves Detection of Proximal Femur Fracture
Official title: Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnoses Disease
Lead sponsor: Centre de l'arthrose, Paris
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.

Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric).


Eligibility criteria: Inclusion Criteria:

* fifth-year medical students

Exclusion Criteria:

* other medical students

Primary outcomes:
measure: accuracy
timeFrame: one month
measure: Sensibility, specificity,
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Aphp
Study officials:
affiliation: APHP
name: cedric maillot
role: STUDY_DIRECTOR
References:
Clinical trial NCT02549378: Study of the Impact of Changes in Carbonemia on Microcirculation in Patients Achieving a Test Hypercapnia
Official title: Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Blood Circulation
Keywords: microcirculation
confocal microscopy
hypocapnia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.

Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .

The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.

Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.


Eligibility criteria: Inclusion Criteria:

* patients from achieving hypercapnia test the CHU of Saint-Etienne
* non smoking
* non diabetic
* affiliated with or entitled to a social security system
* Written consent

Exclusion Criteria:

* subjects not performing the test hypercapnia in full
* patients with dermatological pathology at the study area
* patient with Raynaud's syndrome
* Patients with known bleeding disorders
* refusal to consent

Primary outcomes:
measure: microcirculatory flow (cells / min) measured by confocal microscopy
timeFrame: Day1
Secondary outcomes:
measure: microvessel diameter (micrometer) measured by confocal microscopy
timeFrame: Day1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Laurent Gergelé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03784378: Continued Access to RXDX-105
Official title: RXDX-105 for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring a RET Gene Fusion and a Patient With Ovarian Cancer Harboring a BRAF Gene Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Ovarian Cancer
RET Gene Mutation
BRAF Gene Mutation
Keywords: RXDX-105
Memorial Sloan Kettering Cancer Center
18-487
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 3
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: This study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105.


Eligibility criteria: Inclusion Criteria:

* This individual patient protocol includes treatment for 3 patients previously enrolled on IRB #15-270 (phase1/1b clinical trial RXDX-105-01):

Exclusion Criteria:

* Any patients other than those described above are excluded.

Primary outcomes:
measure: Evaluation during treatment/intervention
timeFrame: Through study completion, up to five years.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alexander Drilon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883597: Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation
Official title: Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Foundation
First posted: 2009-04-17
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to ICU with sepsis and ileostomy

Brief summary: Sepsis is the most frequent cause of death in critically ill patients in non-coronary care Intensive Care Units in the developed world. Microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome.

In particular the intestinal microcirculation is impaired early in the course of the disease. This may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a "gut derived" septic state. Therefore, the impaired intestinal microcirculation has been suggested to act as the "motor of multiple organ failure" in sepsis.

The aim of the project is to evaluate a new diagnostic tool and the impact of Activated Protein C administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for APC therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, SDF).


Eligibility criteria: Inclusion Criteria:

* ileostomy, no infection at the site of stoma, informed consent.
* diagnosed sepsis according to American College of Chest Physicians/Society of Critical Care Medicine criteria13.
* indication for treatment according to hospital guidelines

Exclusion Criteria:

* infection at the site of stoma,
* moribund patients

Primary outcomes:
measure: Microvascular Flow Index (MFI)
timeFrame: 6 hours after treatment
Secondary outcomes:
measure: Leukocyte - endothelial cell interactions, red blood cell velocity
timeFrame: 6 hours after treatment
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Cetnre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT02966197: Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
Official title: the Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa
Placenta Accreta
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 114
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.

Detailed description: Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.

Eligibility criteria: Inclusion Criteria:

* Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.

Exclusion Criteria:

* Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.

Primary outcomes:
measure: blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: operation duration
timeFrame: intraoperative
measure: fluid transfusion
timeFrame: intraoperative
measure: blood transfusion
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06474897: Comparison of Mobilization and Ozone Therapy in Impingement Syndrome
Official title: Comparison of the Efficacy of Mulligan Mobilization and Ozone Therapy in Patients With Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impingement Syndrome
Keywords: Impingement Syndrome
Ozone therapy
Mulligan mobilization
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Mulligan mobilization will be practiced to control group. Pain, range of motion and function will be assessed before and after treatment.

Detailed description: The subacromial bursa and rotator cuff muscles are compressed between the acromion and the proximal humerus. If the subacromial surface volume decreases, degeneration and tears of the soft structures may occur during forward extension and rotation. Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. Mulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. Pain, range of motion and function will be assessed before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients aged 8-65 years
* Patients with shoulder impingement syndrome

Exclusion Criteria:

* Shoulder surgery
* History of scoliosis
* Infection
* Cardiac pacemaker
* Recent myocardial infarction
* Malignancy

Primary outcomes:
measure: Pain assessment
timeFrame: 1 minute
Secondary outcomes:
measure: Range of motion assessment
timeFrame: 1 minute
measure: Function assessment
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Songul Baglan Yentur
Study officials:
References:
Clinical trial NCT01671397: Women's Health Project for Women Wanting to Lose Weight
Official title: Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
weight loss
sleep hygiene
diet
exercise
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.

Detailed description: None needed

Eligibility criteria: Inclusion Criteria:

* Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
* The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)

Exclusion Criteria:

* Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
* Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
* Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program

Primary outcomes:
measure: Weight loss
timeFrame: Six months
Secondary outcomes:
measure: Functional capacity
timeFrame: 6 months
Other outcomes:
measure: Lipid profile
timeFrame: Six months
measure: Quality of life indices
timeFrame: Six months
Locations:
city: Lubbock
country: United States
facility: Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Kenneth M Nugent, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University Health Sciences Center
name: Dolores M Buscemi, MD
role: STUDY_DIRECTOR
References: