louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05336838: Improving Management of Post-partum Haemorrhage With Quantra® System
Official title: Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Partum Haemorrhage
Keywords: Post partum haemorrhage
Bleeding
Labour
Vaginal delivery
Caesarean section
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 mL

Brief summary: Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.

It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.

In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.

In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.


Eligibility criteria: Inclusion Criteria:

Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery

Exclusion Criteria:

* Previous anemia ≤ 7g/dL
* Known bleeding disorders
* Ongoing antiplatelets treatment
* Ongoing anticoagulant treatment

Primary outcomes:
measure: Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
timeFrame: When post partum haemorrhage occurred, within 24 hours after delivery
Secondary outcomes:
measure: Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test
timeFrame: When post partum haemorrhage occurred, within 24 hours after delivery
measure: Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result
timeFrame: When post partum haemorrhage occurred, within 24 hours after delivery
measure: Comparison of Platelet Clot Stiffness result to standard platelet count result
timeFrame: When post partum haemorrhage occurred, within 24 hours after delivery
measure: Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale
timeFrame: When post partum haemorrhage occurred, within 24 hours after delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01822938: Follow-up of Patients' Physical Activity in Post-hospitalization
Official title: Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.


Eligibility criteria: Inclusion Criteria:

* Person having stroke (ischemic or hemorrhagic)
* Whatever the area of stroke
* Person supported by HEMIPASS (monitoring team and home support)
* Stroke less than 6 months
* Patient walking with or without technical or human assistance: FCC score

Exclusion Criteria:

* Disability limiting the gait before the stroke
* Age \< 18 years
* Cognitive impairment limiting participation to the program
* Non signature of the consent
* cardiopulmonary pathology which forbid/banned effort

Primary outcomes:
measure: The distance on the 6 minute walking test (6MWT)
timeFrame: 6 minutes
Secondary outcomes:
measure: Quality of life
timeFrame: at 0 month, 6 months and 12 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
References:
citation: Guediri A, Chaparro D, Borel B, Daviet JC, Compagnat M, Mandigout S. The effect of a home-based coaching program on heart rate variability in subacute stroke patients: a randomized controlled trial. Int J Rehabil Res. 2022 Sep 1;45(3):201-208. doi: 10.1097/MRR.0000000000000529. Epub 2022 May 2.
citation: Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.
citation: Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.
Clinical trial NCT02768038: Intestinal Microbiome and Chronic Inflammatory Bowel Disease
Official title: The Role of Intestinal Microbiome ih the Pathogenesis and Course of Chronic Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colitis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-05-11
Enrollment: 0
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 IBD living at the Turku University Hospital area

Brief summary: The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)

Detailed description: IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.

Eligibility criteria: Inclusion Criteria:

* IBD

Exclusion Criteria:

* patient refusal to participate

Primary outcomes:
measure: Change of microbiome in chronic inflammatory bowel disease
timeFrame: 5 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Head, Department of Gastroenterology
name: Markku Voutilainen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00470938: A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Balance
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-05-08
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Success has been shown in some programs; various exercise interventions place emphasis on strength, balance, or endurance exercises. Results reported in the literature are still equivocal. Controversy exists as to optimal types of exercise, and the optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce device, which places a unique combination of strength and balance demands upon the user, can result in rapid increases in balance as compared to other rehabilitation programs. Gains in balance have implications for geriatric populations as well as those seeking enhanced sports performance and injury prevention. The Purpose of this study is to assess the SpineForce device as a novel intervention in the treatment of balance disorders.


Eligibility criteria: Inclusion Criteria:

* Young, healthy adults between the ages of 20 - 30, asymptomatic with respect to any balance specific disorder, and who are currently enrolled at Logan College.

Exclusion Criteria:Exclusion criteria include:

* A previous lower extremity injury;
* Previous lower extremity surgery;
* A visual or vestibular condition with accompanying balance difficulty;
* A diagnosis of Knee osteoarthritis;
* Currently receiving spinal manipulative therapy;
* Current participation in a regular exercise program;
* Use of any prescription medication, or herbal substance that may affect balance;
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Logan College of Chiropractic
name: Rodger Tepe, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03445338: To Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of K0706 in Plasma and Cerebrospinal Fluid in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of K0706 in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male subjects, 18 to 45 years of age, inclusive, at screening.
2. Willing and able to give written, and dated an informed consent.
3. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions in the Investigator's opinion, and be accessible for follow-up.
4. Medically healthy on the basis of medical history and physical examination.
5. Subjects enrolled in the study should not father a child and follow the necessary precautionary measure to be taken during the course of the study.

Exclusion Criteria:

1. Subjects with a history of a frequent headache, nausea, or vomiting suggestive of increased intracranial pressure.
2. Subject report of recent (6-month) alcohol abuse or illicit drug use or who tests positive at screening, Check-in, or outpatient Visits for breath alcohol and/or drugs of abuse or cotinine;
3. Subjects with a history of any relevant allergy/hypersensitivity.
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results.
5. Subjects who have participated in CSF collection studies within 56 days prior to check-in.
6. Subjects who donated plasma within 14 days prior to the check-in visit.

Primary outcomes:
measure: minimum concentration of study drug cerebrospinal fluid (CSF)
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: SPARC Site 1
state: California
Study officials:
References:
Clinical trial NCT06458738: Clinical Evaluation of a New Printable Denture Base Material
Official title: Clinical Evaluation of a New Printable Denture Base Material: a Prospective Single-arm Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Mouth
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 84 years
* informed consent signed and understood by the subject
* full edentulous patients
* a digital design of the dentures is already existing.
* ability to visit the clinic in person until the baseline recall

Exclusion Criteria:

* patient does not wear the dentures regularly
* mental health status does not allow reliable feedback
* patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
* patients with severe systemic diseases
* poor oral / denture hygiene
* pregnancy

Primary outcomes:
measure: rate of failures leading to replacement of denture
timeFrame: 5 years
Secondary outcomes:
measure: functional (e.g. retention) properties of the dentures
timeFrame: 5 years
measure: biological (e.g. plaque accumulation) properties of the dentures
timeFrame: 5 years
measure: aesthetic (e.g. surface staining) properties of the dentures
timeFrame: 5 years
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT03431038: Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH
Official title: Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
AAA - Abdominal Aortic Aneurysm
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 1800
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosis as OSAHS

Brief summary: This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to analysis risk factors of AAA in OSAHS patients.

Detailed description: Abdominal aortic aneurysm (AAA) is an extremely high mortality disease, and ultrasound has been recommended for the screening of AAA, which is highly sensitive and specific. Studies have shown that screening for AAA in the population can significantly reduce deaths from ruptured abdominal aortic aneurysms. However, those study mainly focus on cardiovascular disease patients or general population, no previous study target on obstructive sleep apnea hypopnea syndrome (OSAHS) population. Retrospective studies show that the incidence of apnea syndrome in patients with abdominal aortic aneurysm is higher than that in the control group, which suggests that OSAHS may be one of the causes of abdominal aortic aneurysm. At present, there is no relevant research on the screening of AAA in OSAHS population.

The main objective of this study was to screen the prevalence of AAA in OSAHS population by a cross-sectional study.

Eligibility criteria: Inclusion Criteria:

* All patients who accept respiratory sleep monitoring in the department of ENT, BTCH, aged over 45 years, from 2018-01-01 to 2019-12-30

Exclusion Criteria:

* 1. Any previous diagnosis of AAA history;
* 2. Received AAA related treatment;
* 3. Past imaging test result suggested increased diameter of the abdominal aorta.
* 4. Poor compliance; refused to follow the requirements set in this study follow-up, and refused to sign informed consent.

Primary outcomes:
measure: Diameter of aorta
timeFrame: 0-48 hours
Secondary outcomes:
measure: ABI
timeFrame: 0-48 hours
measure: Carotid artery stenosis
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Weiwei Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094938: Cardiac Output Monitoring in Aortic Aneurysm Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Keywords: Aortic aneurysm repair
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2010-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Edinburgh based trial in aortic aneurysm repair

Brief summary: To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair

Exclusion Criteria:

* Patients not giving informed consent.
* Patients under the age of 18 years.
* Patients who may be pregnant
* Patients with learning disabilities.
* Rhythm other than sinus rhythm.
* Patients on oral lithium therapy.
* Patients less than 40kg
* Patients with severe mitral regurgitation

Primary outcomes:
measure: Cardiac output
Secondary outcomes:
measure: Arterial Pressure
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
References:
Clinical trial NCT02024308: AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
Official title: A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
AML1-ETO Fusion Protein Expression
Keywords: acute myeloid leukemia,
AML1-ETO fusion protein,
Fludarabine,
recurrence
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 62
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: The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

* Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
* In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
* ECOG (Eastern Cooperative Oncology Group) score: \<2

Exclusion Criteria:

* Serious liver/ kidney dysfunction
* Cardiac function level: 2 above
* Female in pregnancy or lactation
* With serious infection diseases or other diseases

Primary outcomes:
measure: Percentage of participants with disease recurrence
timeFrame: one year
Secondary outcomes:
measure: Percentage of Participants in survival
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Hematology, Changhai Hospital
Study officials:
affiliation: Department of Hematology, Changhai Hospital
name: Xianmin Song, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403608: Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections
Official title: Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Infection
Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having bone or joint infection, with or without device

Brief summary: For patients having a bone or joint infections, with or without device, optimal surgical therapy could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening.

Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care.

The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.


Eligibility criteria: Inclusion Criteria:

* patients having bone or joint infection,
* patients with or without device treated by sub-cutaneous prolonged antibiotic therapy

Exclusion Criteria:

* diabetic foot osteomyelitis
* pressure ulcer-associated osteomyelitis

Primary outcomes:
measure: Description of sub-cutaneous administration of antibiotics for PSAT
timeFrame: 60 months
Secondary outcomes:
measure: Tolerance of sub-cutaneous administration of antibiotics for PSAT
timeFrame: 60 months
measure: Efficacy of sub-cutaneous administration of antibiotics for PSAT
timeFrame: 60 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)
Study officials:
References:
citation: Pouderoux C, Becker A, Goutelle S, Lustig S, Triffault-Fillit C, Daoud F, Fessy MH, Cohen S, Laurent F, Chidiac C, Valour F, Ferry T; Lyon Bone and Joint Infection Study Group. Subcutaneous suppressive antibiotic therapy for bone and joint infections: safety and outcome in a cohort of 10 patients. J Antimicrob Chemother. 2019 Jul 1;74(7):2060-2064. doi: 10.1093/jac/dkz104.