louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03341572: The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
Official title: The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
ARDS
Traumatic Brain Injury
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To observe the effect of PEEP on CVP among patients with different respiratory compliance

Detailed description: 30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.

Eligibility criteria: Inclusion Criteria:

1. Patients with mechanical ventilation and inserted central venous line

Exclusion Criteria:

1. The age is less than 18 years old or more than 80 years old；
2. Pregnant and lying-in woman；
3. Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
4. Patients with norepinephrine dose are greater than 15 micro per minute；
5. Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
6. Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma

Primary outcomes:
measure: CVP
timeFrame: half an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: yi yang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02893072: Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study
Official title: Individualized Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Diabetes, Gestational
Nutrition Therapy
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. The overall purpose of this study is to determine the efficacy of individualized medical nutrition therapy (MNT) intervention to reduce and control the development of GDM.

Detailed description: The number of women with gestational diabetes mellitus had been increasing. Maternal GDM has a great impact on both the health of the mothers and the offspring. Antenatal lifestyle interventions, in particular dietary intervention appear to be feasible to improve maternal GDM and weight gain. To the best of our knowledge, there has been no such trial examining the feasibility of MNT intervention in pregnant women in Hu'nan province. The aim of this study is to evaluate the efficacy of individualized MNT intervention to reduce and control the development of GDM. This is a prospective study, 500 patients who meet inclusion and exclusion criteria will be included. The changes of glucose and weight will be evaluated every two weeks.

Eligibility criteria: Inclusion Criteria:

* Women with gestational diabetes

Exclusion Criteria:

* None

Primary outcomes:
measure: intravenous glucose
timeFrame: every two weeks, from date of randomization until the date of parturition, assessed up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: specify unaffiliated
name: Min Liu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01648972: Gastrografin in Postoperative Ileus
Official title: Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prolonged Postoperative Ileus
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2012-07-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital.

The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Current inpatient following elective laparoscopic or open surgery.
* Classified as having prolonged postoperative ileus.
* Able to understand risks/benefits of the study.
* Able to give informed consent.

Exclusion Criteria:

* Pregnancy.
* ASA of 4 or greater.
* Previous allergic reaction to gastrografin or iodinated contrast agents.
* Manifest hyperthyroidism.

Primary outcomes:
measure: Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.
Secondary outcomes:
measure: Length of hospital stay (days)
timeFrame: Days
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
state: AKL
Study officials:
References:
Clinical trial NCT06718972: A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China
Official title: Database of Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningeal Metastasis
Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
meningeal metastasis
real-world study
database
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-small cell lung cancer patients with Leptomeningeal metastases

Brief summary: This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival/Time to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.

Detailed description: retrospective and prospective study

Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
* Patients who underwent antitumor therapy after diagnosis of LM.

Exclusion Criteria:

* Patients with small cell lung cancer components;
* complicated with tumors other than non-small cell lung cancer.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 6 years
Secondary outcomes:
measure: Time to failure(TTF)
timeFrame: 6 years
measure: Change in cerebrospinal fluid and metabolic markers during treatment
timeFrame: 6 years
measure: Safety during actual clinical treatment
timeFrame: 6 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Sanjiu Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02231372: Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Official title: Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 4602
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 diagonsis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology

Brief summary: Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice


Eligibility criteria: Inclusion Criteria:

* Men and women presenting with symptoms of chronic obstructive pulmonary disease
* Both previously untreated patients and patients treated previously with Berodual® or with other anti-obstructive respiratory tract agents may be included

Exclusion Criteria:

* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Primary outcomes:
measure: Change in overall severity rated on 3-point scale
timeFrame: up to 4 weeks
measure: Change in reduction in breathlessness rated on a 4-point scale
timeFrame: up to 4 weeks
measure: Change in restriction of activity due to breathlessness rated on a 4-point scale
timeFrame: up to 4 weeks
measure: Number of awakening due to nocturnal breathlessness rated on 4-point scale
timeFrame: up to 4 weeks
measure: Global assessment of efficacy by the patients rated on 5-point scale
timeFrame: after 4 weeks
measure: Global assessment of efficacy by the investigator rated on 5-point scale
timeFrame: after 4 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01015872: The Roles of Prostanoids in Patients With Sleep Apnea Syndrome
Official title: The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea syndrome
CPAP
prostanoids
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 46
Sex: ALL
Minimum age (years): 20
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 relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

Detailed description: SAS is characterized by abnormality during sleep and hypoxemia from apnea and hypopnea, followed by systemic inflammation and organ dysfunction like cardiovascular diseases. Systemic inflammation causes the activation of arachidonic acid metabolism, producing prostaglandins (PGs) and leukotrienes (LTs). In addition, significant relationships between PGD2 and PGE2 and sleep, PGF2α and hypertension, PGI2 and thromboxane and platelet aggregation and so on are reported. Therefore, it is hypothesized that many prostanoids affect the pathophysiology of SAS. However, the relationships between prostanoids and clinical outcomes in patients with SAS are unknown. Although CPAP is the major treatment of SAS, the effects of CPAP on prostanoids are not known, either. Thus, the purpose of this study is to evaluate those relationships.

Eligibility criteria: Inclusion Criteria:

* Subjects hospitalized in Kyoto University Hospital for careful examination of SAS

Exclusion Criteria:

* Subjects with severe respiratory diseases, severe heart diseases, severe vascular diseases, or severe diabetes mellitus.
* Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

Primary outcomes:
measure: metabolites of arachidonic acid in the urine and blood
timeFrame: 3 months
Secondary outcomes:
measure: Polysomnography measurements
timeFrame: 3 months
measure: Sleepiness and health-related quality of life
timeFrame: 3 months
measure: Blood pressure and pulse rate
timeFrame: 3 months
measure: Endothelial dysfunction
timeFrame: 3 months
measure: Platelet aggregation
timeFrame: 3 months
measure: Cardiac and neck echo cardiography
timeFrame: 3 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University, Graduate School of Medicine
Study officials:
affiliation: Kyoto Universuty, Graduate School of Medicine
name: Kazuo Chin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: Toru Oga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03451669: Thermal Camera Detection of Ventriculoperitoneal Shunt Flow
Official title: Thermal Camera Detection of Ventriculoperitoneal Shunt Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with VP shunts at the University of Pennsylvania, Department of Neurosurgery

Brief summary: There have been reports in the past of using thermal cameras to demonstrate flow in the tubing as a surrogate of proper shunt function. This was shown to have almost 90% accuracy at determining proper functioning but required expensive equipment that was not universally available. There is now smart phone based thermal camera technology (Flir One: http://www.flir.com/flirone/) that could make this technique widely available for health care use. The goal of the study is to determine if this device can demonstrate flow in the distal tubing of a VP shunt.


Eligibility criteria: Inclusion Criteria:

* Patients with known VP shunt
* Status of shunt function known.
* Patients with well healed wounds (no immediately post op patients)

Exclusion Criteria:

* Patients in urgent need of shunt revision
* Age less than 18

Primary outcomes:
measure: Determine if a smartphone based thermal camera can determine flow in the distal tubing of a VP shunt.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01476969: Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
Official title: Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatic Disease of Heart Valve
Ischemic Reperfusion Injury
Keywords: Ischemia reperfusion injury
Cardiopulmonary bypass
Remote Ischemic Postconditioning
Other Functional Disturbances Following Cardiac Surgery
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.

Detailed description: Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).

Eligibility criteria: Inclusion Criteria:

* rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria:

* infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
* Renal dysfunction
* diabetes
* coronary artery disease
* hypertension
* peripheral vascular disease affecting the lower limb free of arteriovenous fistula
* receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively

Primary outcomes:
measure: Renal function
timeFrame: within the first 48h after cardiac surgery
Secondary outcomes:
measure: concentration of troponin I (cTnI)
timeFrame: within 48h after cardiac surgery
measure: Myocardial enzyme
timeFrame: within 48h after cardiac surgery
measure: Cystatin C
timeFrame: within 48h after cardiac surgery
measure: High-sensitivity c-reactive protein(HS-CRP)
timeFrame: within 48h after cardiac surgery
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Luo Wanjun, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06467968: Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
Official title: GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Inflammation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.

The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.

Detailed description: People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode

Eligibility criteria: Inclusion Criteria:

Persons who have received complete information on the organization of the research and who have signed the informed consent and:

* Age ≥ 18 years old.
* Having read and understood the information document.
* Affiliated to a social security scheme.

Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.

Exclusion Criteria:

Person with

* Hypersensitivity during previous use of 68Ga-DOTATOC
* Impossibility of performing a PET-CT (patient agitated, confused, etc.).
* History of heart disease,
* Severe arrhythmia that does not allow the PET synchronized with the ECG
* Severe renal insufficiency (GFR \<30 ml/min/1.73 m2)
* Treated with a somatostatin analogue.
* Cushing's syndrome
* Pregnant woman, likely to be or breastfeeding
* Adult subject to a legal protection measure (guardianship, curators, legal safeguard)
* Person of legal age unable to express their consent
* Person deprived of liberty by a judicial or administrative decision
* Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1

Primary outcomes:
measure: Relationship between the captation of radiotracer and the cardiovascular disease
timeFrame: 1 day
Secondary outcomes:
measure: Relationship between the captation of radiotracer and the troponin value
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: Veronique Roch
Study officials:
affiliation: CHRU Nancy
name: Mathieu PERRIN, MD
role: PRINCIPAL_INVESTIGATOR
References: