louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06754865: Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
Official title: A Muulticenter, Open, Non-interventional, Retrospective Cohort Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords: Acute exacerbation of chronic obstructive pulmonary disease
Xiyanping injection
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 1140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute exacerbation of chronic obstructive pulmonary disease

Brief summary: The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

1. Discharged with chronic obstructive pulmonary disease;
2. Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
3. The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
4. Study patients with complete medical records.

Exclusion Criteria:

1. Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;
2. Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
3. Patients who do not use intravenous antibiotics;
4. Refuse the case to be used by researchers.

Primary outcomes:
measure: Course of intravenous antibiotics
timeFrame: baseline, at 3(±1), 7(±1), and 10 days during medication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00413465: Study of Renal Blood Flow During Human Endotoxemia
Official title: Renal Plasma Flow During Experimental Human Endotoxemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Type 2 Diabetes
Endotoxemia
Keywords: Renal Plasma Flow
Endotoxemia
Type 2 diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-12-19
Enrollment: 32
Sex: MALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.

Detailed description: Many septic patients develop acute renal failure and the risk is higher in patients with diabetes. The pathogenetic mechanisms behind the development of acute renal failure in connection with sepsis is not completely understood. One among many possible explanations is a change in renal hemodynamics. However, it is still largely unknown what happens to the renal plasma flow during human sepsis. In this study we give endotoxin injection (0,3 ng/kg) to type 2 diabetics and healthy controls as an experimental model of sepsis. Renal plasma flow and glomerular filtration rate are measured by DTPA-renography 1 day before before and 1,25 and 6,5 hours after injection of endotoxin. Furthermore WBC, plasma-cytokines,VCAM-1/ICAM-1, endothelin-1, Thromboxane B2, angiotensin 2, renin and PAI-1 are measured on an hourly basis up to 8 hours after endotoxin injection.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Type 2 diabetes

Exclusion Criteria:

* Renal failure
* Heart failure
* Lung disease

Primary outcomes:
measure: Renal plasma flow, Glomerular filtration rate, Plasma cytokine content, Endotoxemia score, Plasma angiotensin II and renin content, Plasma thromboxane B2 content, Plasma PAI-1 content
Secondary outcomes:
measure: Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Intensiv Care Unit, Rigshospitalet,
Study officials:
affiliation: Rigshospitalet, Denmark
name: Anne Sofie Andreasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03493165: Expanded Access to Everolimus, for an Individual Patient With Uterine Sarcoma (CTMS#18-0020)
Official title: Expanded Access to Everolimus, for an Individual Patient With Uterine Sarcoma (CTMS#18-0020)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Uterine Sarcoma
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2018-04-10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Single patient treatment with everolimus.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00348465: Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds
Official title: An Observational Study to Evaluate the Changes in Prostate Volume Over Time With The Use of Transrectal Ultrasound and Computed Tomography Following Permanent Prostate Brachytherapy With Iodine-125 Seeds.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Brachytherapy
Prostate volume
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate Cancer patients

Brief summary: The size of the prostate changes due to insertion of the radioactive seeds. We will measure the prostate size, before and after the procedure.

Detailed description: The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of prostate cancer
* T1-3 disease
* PSA \<20 ng/ml
* Patient must sign a study-specific informed consent prior to enrollment.

Exclusion Criteria:

* Patients ineligible to brachytherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Hani Ashamalla, MD, FCCP
role: STUDY_CHAIR
affiliation: NY Methodist Hospital
name: Ewa Bieniek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06124365: Shock Wave and Core Exercises for Postpartum Sacroiliac Pain
Official title: Effect of Adding Shock Wave Therapy to Core Stability Exercises in Treatment of Postpartum Sacroiliac Joint Pain: A Single-blinded, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Sacroiliac Joint Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the high popularity and novelty of shock wave therapy (SWT), it is surprising that just one study has examined the effect of SWT on patients with SIJD and their functional ability following treatment by using subjective assessment tools like numeric rating scale (NRS) and limited by its small sample size and lack of long-term follow-up. Therefore, the present study is expected to contribute to the body of knowledge by exploring the effect of adding SWT to core stability exercises in the management of postpartum sacroiliac joint pain.


Eligibility criteria: Inclusion Criteria:

* post-partum women diagnosed with SIJP with limitation of its movement referred from the orthopedist.
* Age is between 25-35 years old.
* Their body mass index will be ranged from 25-35 kg/m2.

Exclusion Criteria:

Patients who have one of the following criteria will be excluded from the study:

* Previous spinal surgery.
* Medical diagnosis other than SIJ dysfunction.
* Patients who had any other spine disorders.
* Patients who had leg length discrepancies.
* Patients with congenital postural deformities.
* Patients with spinal cord injury or acute or unstable neurological signs.
* Patients with cauda equina symptoms related to the spine including changes in bowel or bladder control and perineal sensation.
* Patients with lumber intervertebral disc, spondylosis, lumbar canal stenosis and spondylolysthesis.

Primary outcomes:
measure: Sacroiliac joint pain intensity
timeFrame: change from base line at 6 weeks.
measure: pain pressure threshold
timeFrame: change from base line at 6 weeks.
measure: functional disability
timeFrame: change from base line at 6 weeks
Secondary outcomes:
measure: quality of life
timeFrame: change from base line at 6 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02338765: MoTHER Buddy Program
Official title: With Help From Buddies: The Impact of Social Support Using Mobile Technology on Physical Activity Among Women With Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Obesity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-01-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.


Eligibility criteria: Inclusion Criteria:

1. Physically inactive,
2. having at least one child aged less than 5 years,
3. having at least one family member or friend who can support physical activity engagement and reside in the same community,
4. having access to computer and phone, and
5. overweight/obese (Body Mass Index: 23 kg/m2 or more)

Exclusion Criteria:

1. Having known medical conditions that prevent regular physical activity and
2. current participation in other lifestyle modification programs

Primary outcomes:
measure: Daily steps
timeFrame: weekly during study period, up to 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: Changes in weight over the 12-week study period
measure: Waist Circumference (WC)
timeFrame: Changes in WC over the 12-week study period
measure: Hip Circumference (HC)
timeFrame: Changes in HC over the 12-week study period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT03559465: Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
Official title: Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: systemic sclerosis
B lymphocyte
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.

Detailed description: B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.

Eligibility criteria: Inclusion Criteria:

patients

* systemic sclerosis according to ACR-EULAR 2013
* written consent
* available insurance

Healthy "blood" and healthy "biopsy" controls

* written consent
* available insurance

Exclusion Criteria:

patients

* overlap with other connective tissue diseases
* immunosuppressants in the past 12 months
* corticosteroids ≥10mg/d
* pregnancy or breast feeding

Healthy "blood" and healthy "biopsy" controls

* systemic sclerosis according to ACR-EULAR 2013
* another connective tissue diseases
* immunosuppressants in the past 12 months
* corticosteroids ≥10mg/d
* pregnancy or breast feeding
* With dysimmune inflammatory diseases (except thyroiditis)
* Presenting an infection in progress or within the previous 15 days

Primary outcomes:
measure: Fibroblast transcriptomic : myofibroblast signature
timeFrame: 36 months
Secondary outcomes:
measure: Fibroblast transcriptomic
timeFrame: 36 months
measure: Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
timeFrame: 36 months
measure: Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
timeFrame: 36 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699265: Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing
Official title: Cardiovasculorenal Phenotyping in Fabry Disease Through Noninvasive Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fabry Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2023-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants to be included in this study are patients who are being seen for follow up of known Fabry disease. These patients are screened regularly by the Department of Human Genetics for routine Fabry disease care. All Fabry disease patients who are physically able have a baseline cMRI and CPET performed at their appointment, per local standard of care.

Brief summary: A longitudinal pilot study will be conducted to determine if there are additional testing modalities that are effective in broadly phenotyping subclinical dysfunction in patients with Fabry disease. Individual patients will undergo serial testing over a two-year period to evaluate for changes in their cardiovasculaorenal function during this period. Novel modalities evaluated will include measures of arterial stiffness, ambulatory blood pressure monitoring, cardiopulmonary exercise testing (CPET), and novel serum and urine biomarkers. The benefit of these measures being evaluated is that they are noninvasive, can be performed rapidly, and have reduced costs compared to the current standard screening modalities. Results from these evaluations will be compared to cMRI and standard urine and serum biomarkers performed clinically per local standard of care. The results will also be compared to both published normative data and data from patients with diabetes mellitus, who have a similar microvascular disease process to patients with Fabry disease.


Eligibility criteria: Inclusion Criteria:

* Fabry patients with classical disease
* English speaking, which is needed to assist with obtaining a maximal effort CPET
* No medical contraindications to cardiopulmonary exercise testing or cMRI
* Either treatment naïve or current taking ERT

Exclusion Criteria:

* Physical limitation that would preclude exercise
* Currently prescribed non-ERT treatments for Fabry disease

Primary outcomes:
measure: Peak systolic blood pressure
timeFrame: through study completion, approximately 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03133065: Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Official title: Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to present our experience in treating recurrent HCV genotype 4 infection post living donor liver transplantation (LDLT) since introduction of the second generation direct acting antiviral drugs (DAAs) in Egypt.

Detailed description: This was a cohort study conducted in patients who had undergone LDLT for HCV related disease from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.

Eligibility criteria: Inclusion Criteria:

* All transplanted patients for HCV related disease in the period from 2014 to 2016

Exclusion Criteria:

* Patients transplanted for other causes rather than HCv
* Patients with HBV and HCV co infection

Primary outcomes:
measure: Virologic response at 12 weeks after completion of therapy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00713765: Pharmacokinetic Interaction Between AZD3480 and Donepezil
Official title: A Double-blind, Randomised, Cross-over, Placebo-controlled Study of Repeated Oral Doses of AZD3480 and a Single Dose of Donepezil to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Donepezil in Healthy Extensive and Poor Metabolisers of CYP2D6
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Sodertalje, Sweden
name: Hans Göran Hårdemark
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions, Manchester, UK
name: Simon Constable
role: PRINCIPAL_INVESTIGATOR
References: