louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06462664: Exploring the Impact of Monocytes in Myeloproliferative Neoplasia (EMYNEM)
Official title: Exploring the Impact of Monocytes in Myeloproliferative Neoplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MPN

Brief summary: Impact of monocytes on Myeloproliferative Neoplasm hematopoietic stem cell growth and differentiation in vitro


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MPN in the participating center
* Over 18 yo

Exclusion Criteria:

* Not able to consent

Primary outcomes:
measure: Proliferation and differentiation of hematopoitic stem/progenitor cells
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT03871764: Prediction of Outcome in Severe Preeclampsia
Official title: Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiden Factor V Deficiency,Preeclampsia
Doppler Examination
Palental Pathology
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with preeclampsia in 3rd trimester. Singleton pregnancy. Accurate gestational age confirmed by last menstrual period or sonography before 20 weeks.

Brief summary: this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

Detailed description: leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

Eligibility criteria: Inclusion Criteria: severe preeclampsia in 3rd trimester -

Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.

-

Primary outcomes:
measure: percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature
timeFrame: within 12 wks from diagnosis of severe preeclampsia
measure: percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator
timeFrame: from diagnosis of severe preeclampsia till one week after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01854164: Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
Official title: An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: HGE, impaired fasting glucose, clinical trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).

Detailed description: This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 20-70 years with fasting glucose 100\~126 mg/dL

Exclusion Criteria:

* Abnormal lipid profile values
* Acute/chronic inflammation
* Treated with corticosteroid within past 4 weeks
* Cardiovascular disease
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Participation in any other clinical trials within past 2 months
* Renal disease
* Abnormal hepatic function
* Under hypolipidemic drugs therapy within past 3 months
* Under antipsychotic drugs therapy within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* History of alcohol or substance abuse
* Pregnancy or breast feeding

Primary outcomes:
measure: Changes of blood glucose during OGTT(oral glucose tolerance test)
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of blood insulin during OGTT.
timeFrame: 8 weeks
measure: Changes of glycated albumin, fructosamine, and lipid profile
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT01435564: Pilot Study: Mobile Phone Based Physical Activity in Sedentary Men and Women
Official title: Innovations in Mobile Phone Based Physical Activity- A Pilot of Clinical Trial in Sedentary Men and Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Keywords: Mobile phone
Sedentary lifestyle
Physical activity
Prevention
Health Promotion
Exercise
eHealth
Electronic diary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: National Institute of Nursing Research (NINR)
First posted: 2011-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical activity intervention in sedentary men and women.


Eligibility criteria: Inclusion Criteria:

1. Sedentary lifestyle at work and/or during leisure time
2. Male or female, age between 21-69
3. Access to a telephone at home or a mobile phone
4. Speak and read English
5. BMI between 20-43 kg/m2

Exclusion Criteria:

1. Known medical condition or other physical problems that need special attention in an exercise program
2. Planning a trip out of the United States during the study
3. Pregnant/Delivered a baby during the last 6 months
4. HIV positive
5. Known severe hearing or speech problems
6. Currently participating in lifestyle modification programs or research studies (such as physical activity, diet, and/or weight loss programs)

Primary outcomes:
measure: Pedometer measured steps
timeFrame: 3 months
Secondary outcomes:
measure: 7-Day Physical Activity Recall
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yoshimi Fukuoka, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06404164: Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection
Official title: Artificial Intelligence Pulmonary Watershed Terrain Navigation System for Lung Nodule Localization and Lung Function Preservation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Function Assessment
Disease Free Survival
NSCLC, Stage I
Keywords: Watershed Analysis
wedge resection
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A method of ICG counterstaining localization under target artery occlusion without cutting，It's a new method of localization of small pulmonary nodules.

Detailed description: 1. This technology can replace part of CT puncture-guided positioning, which not only saves CT positioning costs for patients, but also saves time and space resources in CT room;
2. The target artery occlusion technique does not cut off the blood vessels, and the operation is still a wedge resection. Compared with the standard segmentectomy/subsegmentectomy, the steps of cutting off the veins and bronchial tubes are reduced, the operation time is shortened, and the turnover rate is improved.
3. There is less damage to the lung tissue, and the lung function is well preserved. The patients can be discharged in an average of 3 days after the operation, which improves the bed turnover efficiency of the department.

Eligibility criteria: Inclusion Criteria:

1. \<1cm CTR≤0.75; \<1.5cm CTR≤0.5; \<2cm CTR≤0.25 Lung nodules
2. The tumor center is located in the peripheral 2/3 area of the lung field
3. Preoperative analysis and planning of watershed by 3D reconstruction
4. Clinically assessed as cT1aN0M0 stage IA1/cT1bN0M0 stage IA2 (eighth edition), clinically resectable

Exclusion Criteria:

1. No surgical video, no postoperative gross specimen and related distance measurement records
2. The incision edge does not exceed the target nodule diameter from the nodule edge
3. The resection range exceeds 50% of the preoperative planning
4. Postoperative pathological staging non-pT1aN0M0 IA1 stage/pT1bN0M0 IA2 stage (eighth edition)
5. Any situation where the investigator feels the need for extended resection
6. Patients with chronic diseases (such as COPD, pulmonary fibrosis, silicosis) that can cause loss of lung function in patients at risk of progression or potential progression

Primary outcomes:
measure: Lung fuction
timeFrame: 1month 3month 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04773964: Study to Evaluate MET642 in Patients With NASH
Official title: Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: NASH
Fatty Liver
Lead sponsor: Metacrine, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
* Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Exclusion Criteria:

* History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
* Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
* Excessive consumption of alcohol.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 28 days after last dose
measure: Vital Signs
timeFrame: Up to 28 days after last dose
measure: Laboratory tests
timeFrame: Up to 28 days after last dose
measure: ECG
timeFrame: Up to 28 days after last dose
Secondary outcomes:
measure: Pharmacokinetic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacodynamic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacological Activity of MET642
timeFrame: 20 weeks
measure: Pharmacokinetic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacokinetic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacokinetic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacodynamic Profile of MET642
timeFrame: 16 weeks
measure: Pharmacodynamic Profile of MET642
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Pinnacle Research
state: Texas
Study officials:
References:
Clinical trial NCT02476864: Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
Official title: Single-center, Open-label, Randomized, Two-treatment, Single-dose, Crossover Study in Healthy Subjects to Investigate the Biocomparison of the Adult and Pediatric Formulation of Macitentan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: macitentan
biocomparison
safety
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as the marketed macitentan tablet.

Detailed description: The purpose of this study is to establish biocomparison of 2 types of tablets containing macitentan: a pediatric dispersible tablet and the adult film-coated tablet. A single oral dose of each tablet will be given to healthy subjects on 2 different periods separated by a washout phase of 10 to 14 days.

Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan with the two types of tablets using specific statistical methods. The pharmacokinetic parameters will be considered equivalent if specific criteria defined in the study protocol are met.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Healthy on the basis of the physical examination, vital signs (systolic and diastolic blood pressure, heart rate), 12-lead ECG, and laboratory tests performed at screening

Exclusion Criteria:

* History or clinical evidence of any disease and/or condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* History or clinical evidence of alcoholism or drug abuse within the 3 -year period prior to screening
* Excessive caffeine consumption
* Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study
* Previous treatment with any prescribed medications (including vaccines) or over-the counter medications within 2 weeks prior to first study drug administration
* Loss of 250 mL or more of blood within 3 months prior to screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Primary outcomes:
measure: Plasma pharmacokinetic profile
timeFrame: From pre-dose to 216 hours post-dose
Secondary outcomes:
Other outcomes:
measure: Incidence of adverse events
timeFrame: from baseline to Day 10-13 post-dose
measure: ECG abnormalities
timeFrame: from baseline to to Day 10-13 post-dose
Locations:
Study officials:
affiliation: Actelion
name: Patricia Sidharta, PharmD, PhD
References:
Clinical trial NCT02483364: A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)
Official title: A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) and HC-SVT-1002 (Allogeneic Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudoarthrosis
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 12
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
Intervention model description: Cell therapy
Primary purpose: TREATMENT

Brief summary: The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex between 18 and 65 years of age (both inclusive).
* Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.

Exclusion Criteria:

* Present infection (infection signs should not be evidenced).
* Other lesions which interfere with the body weight load.
* Open pseudoarthrosis (at the time of inclusion).
* Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
* Other conditions or circumstances that compromise the study participation according to medical criteria.

Primary outcomes:
measure: Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
timeFrame: Up to 24 months after surgery.
measure: Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
timeFrame: Within 6 months after surgery.
Secondary outcomes:
measure: Comparative statistical analysis
timeFrame: Up to 24 months after surgery.
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Laboratorios Salvat, S.A.
state: Barcelone
Study officials:
affiliation: Laboratorios Salvat
name: Enrique Jimenez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04459364: The Prevalence of Pulmonary Hypertension in Patients With COVID-19.
Official title: The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Right Ventricular Overload
COVID
Lead sponsor: Attgeno AB
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This is a non-interventional retrospective study to be performed in an intensive care unit in Sweden. The study will include 80 Covid-19 patients who had been examined with echocardiography. Data will be collected through chart review.

Brief summary: The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults.

However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.

Detailed description: Demographics and data from study variables will be documented in paper CRFs at the investigational site.

* Demography

  o Age, sex
* Covid-19 related variables

  o COVID-19 diagnosis
* Concomitant diseases

  o Comorbidity, previous and present
* Cardiovascular risk factors

  o Smoking
* Laboratory values
* On-site measurements o Evaluation with echocardiography

Eligibility criteria: Inclusion Criteria:

* Men and women at least 18 years of age
* Diagnosed with COVID-19 and is treated at an intensive care unit.

Exclusion Criteria:

* Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.
* Missing verified diagnosis of COVID-19

Primary outcomes:
measure: Prevalence
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Per-Arne Lönnqvist, Professor
role: PRINCIPAL_INVESTIGATOR
References: