louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02126800: Rapid Medical Donation Programme for Breast Cancer
Official title: Rapid Medical Donation Programme for Breast Cancer to Examine Tumour Heterogeneity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Keywords: breast cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Breakthrough Breast Cancer
name: Institute of Cancer Research, United Kingdom
First posted: 2014-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven metastatic breast cancer

Brief summary: Treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. Only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases.

Even when one deposit responds to a new treatment, a neighbouring one may continue to grow. There is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments.

This study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. Patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis.

Main aims:

* To comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites.
* To map the natural history of the metastatic breast cancer process


Eligibility criteria: Inclusion Criteria:

* Patients who have completed active treatment (or trials) for metastatic breast cancer.
* Patients referred to either community or the hospital-based palliative care unit from Royal Marsden National Health Service Foundation Trust.

Exclusion Criteria:

* Lack of capacity / inability to give informed consent.
* Diagnosis of alternative cancer within the last 5 years other than resected basal cell skin cancer or cervical intraepithelial neoplasia.
* Patients known to be HIV, Hepatitis B virus or Hepatitis C virus positive on serology .
* Spongiform encephalopathy (known or suspected CJD) .
* Eligibility for or current participation in a clinical trial (excluding palliative care trials)

Primary outcomes:
measure: The acquisition of tumour tissue from multiple metastatic sites.
timeFrame: Within 6 hours from the time of death.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Peter A Barry, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00781300: Intraocular Pressure With Loteprednol and Dexamethasone
Official title: A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: Intraocular pressure
Pterygium
Surgery
Steroids
Glaucoma
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.

Detailed description: Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.

Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.

Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.

Eligibility criteria: Inclusion Criteria:

* Age: eighteen years old or more
* IOP: less than 22mmHg

Exclusion Criteria:

* History of previous ocular surgery
* Use of topical or systemic corticosteroids for up to a month before the surgery
* Extensive pterygia that disabled accurate IOP measurement

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Once a week for the first 4 weeks and 6 weeks after the procedure
Secondary outcomes:
measure: IOP difference between the operated eye and the fellow eye
timeFrame: Once a week for the first 4 weeks and then 6 weeks after the procedure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Opthalmology, Federal University of São Paulo
state: SP
Study officials:
affiliation: Fedreal University of São Paulo
name: Luciano M Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764800: The Prevalence of Micronutrient Deficiency in Early School-age Children
Official title: The Prevalence of Micronutrient Deficiency in Early School-age Children and Its Correlation With Eating Behavior, Dietary Habits, Development, Physical Activity, Nutritional Status and Health Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Micronutrient Deficiency
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional descriptive study uses a structured questionnaire to elicit information from parents in Taiwan who are early school-age children aged 4-7 years (\<7 years old). Participants are recruited from clinic in Chang Gung Children's medical center, Chang Gung Memorial Hospital. A total of 250 participants who meet the eligibility criteria are enrolled.

Brief summary: This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status.

Detailed description: A structured questionnaire is used to conduct a cross-sectional descriptive study of 250 early school-age children aged 4-7 years (\<7 years old) in Taiwan. Data collection would include: demographics, food preferences, eating behavior, body weight and height, body mass index (BMI), physical activity, records of medical illness, peripheral cell blood count, serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and compared using standard statistical tests. The correlations among eating behavior, dietary habits, development, physical activity, nutritional status, and health status, and micronutrient deficiency are evaluated.

Eligibility criteria: Inclusion Criteria:

* 4-7 years old (\<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire

Exclusion Criteria:

* At the time of the enrollment, there is an acute infection (respiratory, gastrointestinal or urinary tract), and there are organic diseases (heart, lung, brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).

Primary outcomes:
measure: Change serum concentrations of Hb (g/dL) may be found in children's serum
timeFrame: On the day of enrollment
measure: Change serum concentrations of ferritin (ng/ mL) may be found in children's serum
timeFrame: On the day of enrollment
measure: Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum
timeFrame: On the day of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsun-Chin Chao, A.P.
role: STUDY_CHAIR
References:
Clinical trial NCT03905200: Study on the Value of Three-dimensional Speckle Tracking Technique
Official title: Study on the Value of Three-dimensional Speckle Tracking Technique in the Diagnosis and Follow-up of Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography, Three-Dimensional
Coronary Artery Disease
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: According to reference, the area under the ROC curve of 3d-STI strain peak and strain peaking time for the diagnosis of coronary heart disease is about 0.65.In this study, it is expected that the combined diagnosis model can increase the area under the ROC curve to the level of 0.85, and the standard deviation of the area under the ROC curve is estimated to be 0.5. In order to get 85% assurance, we plan to include 827 subjects.

Brief summary: For a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. This trial is to explore the screening and diagnostic value of three-dimensional speckle tracking technology for coronary heart disease, and the evaluation value of 3D speckle track image(3D-STI) technology for cardiac function improvement after coronary intervention, and to seek reliable, accurate and quantifiable non-invasive imaging examination for the diagnosis, follow-up and prognosis of coronary heart disease.

In this study, coronary angiography is taken as the "gold standard", and 3d-STI echocardiography technology is proposed to combine with clinical characteristics of subjects for joint diagnosis, so as to evaluate the value of 3d-sti technology in the diagnosis of coronary heart disease.

Patients were followed up with echocardiography after interventional treatment to explore the feasibility of 3D-STI technology in evaluating cardiac function improvement.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with coronary heart disease
* patients underwent coronary angiography with or without PCI

Exclusion Criteria:

* patients with non-sinus rhythm
* patients with severe heart valvular disease
* patients with severe cardiomyopathy
* patients with congenital heart disease
* patients with severe heart failure stage
* patients with acute myocardial infarction occurred during follow-up
* patients with other extremely severe illness
* patients whose images are not clear enough to mark the endocardium

Primary outcomes:
measure: Left ventricular myocardial viability
timeFrame: half an hour
Secondary outcomes:
measure: The value of 3D-STI technology on the improvement of left ventricular myocardial function
timeFrame: half a year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01843400: Regorafenib Post-marketing Surveillance
Official title: Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Regorafenib
Colorectal Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 1301
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable, metastatic or recurrent colorectal cancer

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.


Eligibility criteria: Inclusion Criteria:Patients

* who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

* Patients who have previously received Regorafenib/ STIVARGA

Primary outcomes:
measure: Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
timeFrame: Up to 6 months
measure: Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of pateints with ADRs in subpopulations
timeFrame: Up to 6 months
measure: Number of patients with SAEs in supopulations
timeFrame: Up to 6 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
measure: Overall survival in subpopulations
timeFrame: Up to 12 months
measure: Time to treatment failure (TTF)
timeFrame: Up to 12 months
measure: Time to Treatment failure in subpopulations
timeFrame: Up to 12 months
measure: Tumor response assessed by RECIST or physicians own evaluation
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06112600: The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination
Official title: The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pediatric Patient
Fear
Virtual Reality
Nursing Caries
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 126
Sex: ALL
Minimum age (years): 48
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective, randomised controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.


Eligibility criteria: Inclusion Criteria:

* being 48 months
* being conscious (with the ability to communicate).

Exclusion Criteria:

* Having a physical and psychological condition that prevents them from wearing glasses to view VR;
* Having a visual problem
* Having mental or physical disabilities
* Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
* Having chronic or life-threatening disease
* Refusing the VR or kaleidoscope intervention during vaccine injection.

Primary outcomes:
measure: Procedural Pain
timeFrame: 1 year
measure: Fear
timeFrame: 1 year
measure: Anxiety
timeFrame: 1 year
Secondary outcomes:
measure: Parental satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References:
Clinical trial NCT02965300: The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
Official title: The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasm
Lung Disease
Keywords: Pulmonary lesion
Volatile Organic Compositions(VOCs)
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lung disease or healthy controls without lung diseases， and can cooperate with the collection of exhaled breath.

Brief summary: The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups.

Detailed description: Collect the exhaled gas in pulmonary lesion patients and healthy controls, using proton transfer reaction mass spectrometry to analysis the different composition and concentration of VOCs, to find the biomarker gases of distinguishing benign and malignant lesion of lung among different groups， and try to build a diagnostic model for lung lesion.

Eligibility criteria: Inclusion Criteria:

* cohort 1 :

Inclusion criteria:

Patients newly diagnosed with primary lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.

Age ≥ 18 years

* cohort 2： Inclusion criteria： Patients diagnosed with pulmonary benign lesion by tissue biopsy or other examination.

Age ≥ 18 years

Exclusion Criteria:

patients who have more than one type of carcinoma patients diagnosed type 2 diabetes mellitus patients diagnosed chronic renal failure patients diagnosed upper digestive tract ulcer patients who reject to sign the informed consent from

* cohort 3： Healthy controls Volunteers without diagnosed lung diseases and pulmonary symptoms.

Primary outcomes:
measure: Mass-to-charge Ratio
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: department of respiratory department ,Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: liang-an Chen, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566300: Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars
Official title: Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scars
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.


Eligibility criteria: Inclusion Criteria:

* 1. Males and females between 18-60 years old. 2. Post-burn or traumatic atrophic scar \> 6 months duration (16). 3. Patients not receiving any treatments for the scar within the past 3 months.

Exclusion Criteria:

* 1. Patients with contractures, hypertrophic and keloid scars. 2. Patients with history of bleeding disorders or coagulopathy, or on anticoagulant therpy.

  3. Diabetes and other systemic diseases that may be complicated by the procedure.

  4. Pregnant and lactating females. 5. BMI less than 18.5 6. Patients with scars at the donor site

Primary outcomes:
measure: change in the scar by by the patient and observer scar assessment scale (POSAS).
timeFrame: 6 months after the proceedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT02356900: Hyperbaric VO2max Study
Official title: Effects of High Intensity Interval Training in a Hyperoxic-hyperbaric Environment on Exercise Performance at Altitude
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Exercise Training
Keywords: interval training
hyperbaric oxygen
VO2 max
altitude
exercise performance
mitochondrial oxidative capacity
mitochondrial biogenesis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric environment for exercise performance at altitude. Subjects will complete a short, high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after this training phase, all subjects will be tested for maximum aerobic capacity at a simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of mitochondrial oxidative capacity in a skeletal muscle biopsy.

A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.


Eligibility criteria: Inclusion Criteria:

* healthy, recreationally active or sedentary individuals

Exclusion Criteria:

* VO2max \< 35 ml/kg/min - male 30 ml/kg/min - female
* chronic cardiovascular or pulmonary diseases
* history of pneumothorax
* active smoker
* pregnant women
* non-english speaking
* not in full mental capacity
* blind
* sickle cell trait or disease

Primary outcomes:
measure: Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )
timeFrame: Baseline and <72 hrs Post-training
measure: Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)
timeFrame: Baseline and <72 hrs Post-training
measure: Mitochondrial Mass Change
timeFrame: Baseline/24 hrs Post-training
measure: Tfam Muscle Protein Content Change
timeFrame: Baseline/24 hrs Post-training
measure: Pgc-1a Coactivator Muscle Protein Content Change
timeFrame: Baseline/24 hrs Post-training
measure: COX-I Gene Expression Change
timeFrame: Baseline/24 hrs Post-training
measure: Muscle Phenotype Change
timeFrame: Baseline/24 hrs Post-training
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References:
citation: Alvarez Villela M, Dunworth SA, Kraft BD, Harlan NP, Natoli MJ, Suliman HB, Moon RE. Effects of high-intensity interval training with hyperbaric oxygen. Front Physiol. 2022 Aug 19;13:963799. doi: 10.3389/fphys.2022.963799. eCollection 2022.