louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02663557: The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke
Official title: Evaluating the Influence of Day-to-day Blood Pressure Variation in Acute Ischemic Stroke on Adverse Outcomes in Long-term Post-stroke Followup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke, blood pressure, prognosis
Lead sponsor: Dongguan People's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-01-26
Enrollment: 400
Sex: ALL
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: patients with acute ischemic stroke, which should be verified by define radiological evidences and acute onset of clinical manifestations.

Brief summary: Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to be a major modifiable risk factor for stroke.Even the casual visit hypertension has been managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure variability (BPV) contribute to recurrent stroke.

Detailed description: System hypertension has been reported to play the most important role in the development of stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary prevention. However, even though some proper measures have been taken,there is still surplus risk for recurrent stroke. Recently the variation of system blood pressure has been focused as the candidate of another risk factor.Up to date,this hypothesis remains an intense debate and few studies has been done to clarify it.Besides, the definition of BPV and measurement of BPV parameters are still beyond conformity.In the current study, the long-term and short-term BPV will be taken respectively for patients with prior stroke. Bsed on these parameters, the cohort will be followed up for average 2 years. The predefined outcome include composite cardiovascular events, neuropsychiatric wording, and mortality during followup.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* comorbidity of dementia ( including AD, PDD, FTLD, VaD and so on )
* coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease that would influence mortality.
* discharge with severe sequelae with mRS\>5

Primary outcomes:
measure: mortality
timeFrame: 12 months
Secondary outcomes:
measure: macrovascular events
timeFrame: 12 months
measure: microvascular events
timeFrame: 12 months
Other outcomes:
measure: non-cardiovascular events
timeFrame: 12 months
Locations:
city: Dongguan
country: China
facility: Dongguan Peoples' Hospital
state: Guangdong
Study officials:
affiliation: dongguan peoples' hospital
name: Zhu Shi, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06612957: A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section
Official title: A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Scar Diverticulum
Lead sponsor: Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the efficacy and safety of uterine incision diverticulum repair during repeat cesarean section.The main questions it aims to answer are:

* Can this surgical method improve the symptom of menorrhagia？
* Is this procedure safe？ Researchers will compare experimental group(Cesarean section + diverticulum repair group) to control group(Conventional cesarean section group) to see if this surgical method works to treat or improve menorrhagia.

Participants will:

* randomly assigned 1:1 to the experimental group（repairing uterine diverticula during cesarean section) and the control group （Routine cesarean section without repairing the uterine incision diverticulum）
* visit the hospital 42 days after surgery
* followed up by telephone 6-12 months after surgery


Eligibility criteria: Inclusion Criteria:

* Women aged ≥18 years, gestational age ≥37 weeks, singleton pregnancy, previous lower segment cesarean section, second or third cesarean section, and diagnosed with uterine incision diverticulum by imaging before or during early pregnancy.

Exclusion Criteria:

* Preoperative indications of placenta accreta or previa, interdelivery interval less than 18 months from the last cesarean section, history of other uterine surgeries, and severe obstetric or medical complications requiring emergency care.

Primary outcomes:
measure: Regularity of postpartum menstrual cycle
timeFrame: Six months after cesarean section
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02380248: Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
Official title: Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.


Eligibility criteria: Inclusion Criteria:

* Must give informed consent, and be willing and able to attend all study visits.
* Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
* Dry eye in both eyes diagnosed by an ophthalmologist.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
* Any contraindications or hypersensitivities to the study medications or their components.
* Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening.
* Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
* Participation in any other clinical trial within 30 days prior to Screening.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Corneal Staining at All Study Time Points
timeFrame: Baseline (Day 0), Day 45, Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Karnataka
country: India
facility: Contact Alcon India for Trial Locations
Study officials:
affiliation: Alcon Laboratories Pvt Ltd (India)
name: Head, CTM, Med Affairs
role: STUDY_DIRECTOR
affiliation: Alcon, A Novartis Division
name: Sr. Clinical Manager, Global Trial Leadership
role: STUDY_DIRECTOR
References:
Clinical trial NCT06553248: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of GZR4 in Chinese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: GZR4
PK
PD
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 36
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: This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or female at the age of 18-65 (inclusive) at the time of informed consent
* Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
* Diagnosis of type 2 diabetes mellitus for over 3 months
* Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.

Exclusion Criteria:

* History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
* Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
* Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
* Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
* Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms

Primary outcomes:
measure: Incidence of TEAE
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: AUC0-inf
timeFrame: Week 6
measure: AUC0-last
timeFrame: Week 6
measure: AUC0-168h
timeFrame: Week 1, Week 6
measure: Tmax,GZR4
timeFrame: Week 1, Week 6
measure: ADA of GZR4
timeFrame: Baseline to Week 10
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
state: Beijing
Study officials:
References:
Clinical trial NCT02375048: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
Official title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer of Breast
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 179
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Detailed description: Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Eligibility criteria: Inclusion Criteria:

* 55\< Age \<70
* Tumor size ≤ 2 cm
* pN0 (SN biopsy or ALND)
* ER/PgR positive
* Margins \> 5 mm (either at initial surgery or at re-excision)
* Clips placed in the surgical bed (minimum of 4 clips)
* Unicentric only
* No lymphovascular invasion
* Any grade
* No extensive intraductal component (\>25%)
* Written informed consent

Exclusion Criteria:

* Prior thoracic radiation therapy
* Oncoplastic surgery / No clips in the surgical bed
* Multicentric cancer
* Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae

Primary outcomes:
measure: Toxicity will be measured with CTCAE v.4.0
timeFrame: ten years
measure: Cosmesis will be measured with Harvard scale
timeFrame: ten years
Secondary outcomes:
measure: Rate of Local Control
timeFrame: ten years
measure: Disease Free Survival
timeFrame: ten years
measure: Overall Survival
timeFrame: ten years
measure: Quality of Life Questionnaire
timeFrame: ten years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Marta Scorsetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847248: HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
biomarker
HSPA12B
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Continuous patients with sepsis, severe sepsis, SIRS after major orthopedics surgery and healthy volunteers

Brief summary: * Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
* HSPA12B is primarily located in endothelial cells and detectable during sepsis.
* The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients meet the diagnostic criteria according to the grouping

Exclusion Criteria:

* patients without informed consent
* patients who were undergoing continuous renal replacement therapy before sampling
* patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital
name: Ke-ming Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01494948: Innate Immunity and the Allergic Response
Official title: Innate Immunity and the Allergic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Allergies
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease.

Detailed description: A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. Normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.

Eligibility criteria: Inclusion Criteria:

1. Must give written informed consent before any study related activity is performed
2. Male and female adult and adolescent patients aged ≥18 years and ≤ 65 years.
3. Allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years.

Exclusion Criteria:

1. The presence of any of these diseases: Atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic).
2. Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
3. The use of any intranasal and inhaled corticosteroids within the last month.
4. Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
5. Current pregnancy.
6. Women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding
7. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
8. Use of any other investigational agent in the last 30 days

Primary outcomes:
measure: Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge.
timeFrame: 1month
Secondary outcomes:
measure: Change in immune cell numbers in the nasal lavage following allergen challenge
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wisconsin
name: Mitchell Grayson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sigua JA, Buelow B, Cheung DS, Buell E, Hunter D, Klancnik M, Grayson MH. CD49d-expressing neutrophils differentiate atopic from nonatopic individuals. J Allergy Clin Immunol. 2014 Mar;133(3):901-4.e5. doi: 10.1016/j.jaci.2013.09.035. Epub 2013 Dec 18. No abstract available.
Clinical trial NCT05491148: Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
Official title: Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift
Keywords: functional state of the body
medical personnel
heart rate variability
cognitive functions
cardiovascular system
Lead sponsor: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy medical workers in neonatal intensive care unit

Brief summary: The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work.


Eligibility criteria: Inclusion Criteria:

* the volunteer has practical experience in the neonatal intensive care unit
* digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology

Exclusion Criteria:

* acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys
* body temperature above 37 ° C, heart rate over 90 beats / min, systolic and diastolic blood pressure above 140 mm Hg. Art. and 90 mm Hg. Art.
* organic brain lesions, increased convulsive activity in history
* receiving more than 10 units. alcohol per week or history of alcoholism, drug addiction, drug abuse

Primary outcomes:
measure: Heart rate
timeFrame: 8 hours
measure: Blood pressure
timeFrame: 8 hours
measure: Anthropometry (Height)
timeFrame: 1 hour
measure: Anthropometry (Weight)
timeFrame: 1 hour
measure: Body temperature
timeFrame: 1 hour
measure: Electrocardiography
timeFrame: 1 hour
measure: Cognitive functions test 1
timeFrame: 1 hour
measure: Cognitive functions test 2
timeFrame: 1 hour
measure: Cognitive functions test 3
timeFrame: 1 hour
Secondary outcomes:
measure: Survey
timeFrame: 1 hour
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Study officials:
affiliation: Junior scientist
name: Inga Malakhova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726648: CDP323 Biomarker Study
Official title: Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Relapsing Multiple Sclerosis
Keywords: CDP323
Relapsing multiple sclerosis
Blood biomarkers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2008-08-01
Enrollment: 71
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: BASIC_SCIENCE

Brief summary: Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Female and male subjects aged 18-65 years
* Relapsing form of MS with at least one clinical relapse in the 24 months before screening;
* Screening EDSS score of 0-6.5;
* Must be fully immunocompetent
* Female subjects of childbearing potential must agree to practice contraception methods

Exclusion Criteria:

* Any conditions that could interfere with the contrast-enhanced MRI;
* Any clinically significant disease state or findings other than MS;
* Any clinically significant deviation from the pre-defined ranges for laboratory tests;
* Concomitant treatment with MS disease modifying drugs

Primary outcomes:
measure: Pharmacodynamic parameters related to leukocyte trafficking
timeFrame: 4 weeks
Secondary outcomes:
measure: Standard and disease-related safety variables
timeFrame: 4 weeks
measure: Class-related safety parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tooting
country: United Kingdom
state: London
city: Croydon
country: United Kingdom
state: Surrey
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wolf C, Sidhu J, Otoul C, Morris DL, Cnops J, Taubel J, Bennett B. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study. PLoS One. 2013;8(3):e58438. doi: 10.1371/journal.pone.0058438. Epub 2013 Mar 5.