louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01761669: Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 healthy volunteers

Brief summary: Working hypothesis and aims: The aim of our study is to investigate whether vitamin D deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers.

Methods:

In total 400 healthy volunteers are planned for inclusion in this trial. After signing an informed consent two blood samples will be obtained from each participant.

Expected results: invastigator expect to find that volunteers with vitamin D deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin D


Eligibility criteria: Inclusion Criteria: age \>18 healthy naive to drug treatment -

Exclusion Criteria:

no exc criteria

-

Primary outcomes:
measure: the correlation between vitamin D levels and endogenous thrombin potential
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmekMC
Study officials:
affiliation: Emek Medical Center
name: mazen elias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144569: PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
Official title: the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2 Insertion Mutation Positive Advanced NSCLC
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer


Eligibility criteria: Inclusion Criteria:

* Advanced non-small cell lung cancer confirmed by histology or cytology
* HER2 insertion mutation-positive
* Failure with first-line standard chemotherapy
* with measurable lesions.

Exclusion Criteria:

* no measurable tumor lesions
* Patients received PD-1 or Pyrotinib before

Primary outcomes:
measure: PFS
timeFrame: Approximately 1 years
Secondary outcomes:
measure: ORR
timeFrame: Approximately 1 years
measure: OS
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04559269: Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests
Official title: Micro-sleep During Maintenance Wakefulness Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lobectomy
Hepatectomy
Pancreaticoduodenectomy
Keywords: Maintenance Wakefulness Tests
micro-sleep
sleepiness
latency
EEG
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and wakefulness tests, generally with a view to authorizing driving.

Brief summary: During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Detailed description: Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP

Eligibility criteria: Inclusion Criteria:

* Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and MWT, in order to evaluate their sleepiness (usually before they resume driving)
* hospitalized in the Center for Sleep Medicine (Hôpital Lyon Croix Rousse) between September 2017 and January 2019

Exclusion Criteria:

* patient with active encephalopathy or epilepsy whose EEG was abnormal
* denial of study participation
* availability of all the recordings (n=4 tests) of the MWT

Primary outcomes:
measure: TThe primary endpoint was to determine if LepMAP was better than ΔMAP for the prediction of hypotensive event at 1, 2 and 5 minutes, defined as a mean arterial pressure of less than 65 mmHg
timeFrame: Only during perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse / GHN
Study officials:
References:
Clinical trial NCT04472169: UPLC-MS/MS Monitoring of Emicizumab Therapy
Official title: Value of Emicizumab Monitoring With UPLC-MS/MS for Bleeding Risk Prediction in Severe Hemophilia A
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A
Keywords: Drug monitoring
Severe Hemophilia A
Emicizumab
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2020-07-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients with severe hemophilia A will be included in the study on 2 french Hemophilia Treatement Centers (CHU Lille and CHU Caen)

Brief summary: Emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia A with or without inhibitors. Some heterogeneity in residual emicizumab concentrations have been reported according to age, body mass index or drug therapeutic regimen. Some cases of neutralizing antidrug antibodies have been also reported. Whether monitoring emicizumab plasma concentration could predict the residual bleeding risk under emicizumab is unknown. As conventional coagulation assays are not adapted for emicizumab monitoring, this study aims to assess the value of monitoring residual emicizumab plasma concentration by UPLC-MS/MS in bleeding risk prediction.


Eligibility criteria: Inclusion Criteria:

* Adult or child with Clinical diagnosis of severe hemophilia A (FVIII activity \< 1%) with or without inhibitor
* Clinical indication to emicizumab therapy

Exclusion Criteria:

* Refusal to give informed consent
* acquired hemophilia A
* other inherited or acquired bleeding disorder
* bodyweight \< 10 kgs

Primary outcomes:
measure: Area under the curve ROC of Residual plasma level of emicizumab
timeFrame: At Week 5 (end of emicizumab loading period)
Secondary outcomes:
measure: Residual plasma level of emicizumab measured by UPLC-MS/MS
timeFrame: At Week 5 (end of emicizumab loading period)
measure: Residual plasma level of emicizumab measured by UPLC-MS/MS
timeFrame: At each breakthrough bleeding until end of study
measure: Residual plasma level of emicizumab (UPLC-MS/MS dosing)
timeFrame: At Week 5 and at each breakthrough bleeding until end of study
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: Institut Coeur-Poumon, Pôle d'Hématologie-Transfusion, CHU
Study officials:
affiliation: University Hospital, Lille
name: Antoine Rauch, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06202469: Creatine and Ubiquinol for Sperm Quality
Official title: The Effects of 8-week Creatine Supplementation With and Without Ubiquinol on Sperm Quality Biomarkers in Normospermic and Oligospermic Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligospermia
Sperm Count, Low
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 35 years
* Sperm quality test available (at least half will have low sperm quality)
* Informed consent
* Healthy BMI (18.5 - 24.9 kg/m2)

Exclusion Criteria:

* Major chronic disease and acute injuries
* History of dietary supplement use during the past 28 days
* No consent to randomization
* Participation in other studies

Primary outcomes:
measure: Sperm concentration
timeFrame: Change from baseline sperm concentration at 8 weeks
Secondary outcomes:
measure: Total antioxidant capacity
timeFrame: Change from baseline total antioxidant capacity at 8 weeks
measure: Creatine kinase
timeFrame: Change from baseline creatine kinase at 8 weeks
measure: Creatine
timeFrame: Change from baseline creatine at 8 weeks
measure: The World Health Organisation-Five Well-Being Index (WHO-5)
timeFrame: Change from baseline WHO-5 at 8 weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied Bioenergetics Lab
state: Vojvodina
Study officials:
affiliation: University of Novi Sad
name: Sergej Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostojic SM, Stea TH, Engeset D. Creatine as a Promising Component of Paternal Preconception Diet. Nutrients. 2022 Jan 28;14(3):586. doi: 10.3390/nu14030586.
Clinical trial NCT00456469: Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children
Official title: Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Keywords: TB
latent
infection
Ethiopia
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2007-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

Detailed description: The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses.

Children with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

Eligibility criteria: Inclusion Criteria:

- Children - 1 to 14 years old in contact with adults with smear positive TB

Or:

- Children with suspicion of TB admitted to the hospital for investigations

Exclusion Criteria:

- Residency \> 10 Km from recruitment center

Or:

- Patient severely to undergo diagnostic procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Awassa
country: Ethiopia
facility: Bushullo Major Health Centre
state: Southern Region
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: Luis Cuevas, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yassin MA, Petrucci R, Garie KT, Harper G, Teshome A, Arbide I, Asnake G, Ahmed HJ, Mammo T, Yesuf K, Cuevas LE. Use of tuberculin skin test, IFN-gamma release assays and IFN-gamma-induced protein-10 to identify children with TB infection. Eur Respir J. 2013 Mar;41(3):644-8. doi: 10.1183/09031936.00012212. Epub 2012 Sep 20.
citation: Garie KT, Yassin MA, Cuevas LE. Lack of adherence to isoniazid chemoprophylaxis in children in contact with adults with tuberculosis in Southern Ethiopia. PLoS One. 2011;6(11):e26452. doi: 10.1371/journal.pone.0026452. Epub 2011 Nov 1.
citation: Yassin MA, Petrucci R, Garie KT, Harper G, Arbide I, Aschalew M, Merid Y, Kebede Z, Bawazir AA, Abuamer NM, Cuevas LE. Can interferon-gamma or interferon-gamma-induced-protein-10 differentiate tuberculosis infection and disease in children of high endemic areas? PLoS One. 2011;6(9):e23733. doi: 10.1371/journal.pone.0023733. Epub 2011 Sep 23.
Clinical trial NCT01820169: Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
Official title: Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive effect on the subjects overall glycemic control.


Eligibility criteria: Inclusion Criteria:

1. Age:= and \>20 years. 2. Intend to paticipate in this study after education of structured testing. 3.HbA1c:= and \>7.5% in the recect 2 months.

Exclusion Criteria:

1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor

Primary outcomes:
measure: Improvement in HbA1c in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: 1. Comparison with historical control in HbA1c change.
timeFrame: Baseline to 6 months
measure: 2. Change in blood gulucose.
timeFrame: Baseline to 6 months
measure: 3. Change in BMI.
timeFrame: Baseline to 6 months
measure: 4. Occurance of sever hypoglycemia.
timeFrame: Baseline to 6 months
measure: 5. Doctor's opinion for Accu-Chek 360° View.
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
Study officials:
affiliation: National organization Hospital Kyoto Medical Center
name: Naoki Sakane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01544569: Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors
Official title: Endogenous DNA Transposition in Rhabdoid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: rhabdoid tumor of the kidney
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-06
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rhabdoid tumors

Brief summary: RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.

Detailed description: OBJECTIVES:

* To investigate the expression and function of transposons in 50 primary rhabdoid tumors.

OUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age
* Clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Expression and function of transposons in rhabdoid tumors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Elizabeth A. Mullen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108169: Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.
Official title: A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Surgery
Keywords: Coronary artery bypass graft
Left Atrial Appendage Occlusion
stroke
prevention
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.


Eligibility criteria: Inclusion Criteria:

1. Subject undergoing coronary artery bypass grafting according to clinical indications;
2. Age is more than 18 and less than 80 years old;
3. Male and non pregnancy female;
4. Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

1. Pregnancy female;
2. Participate in other clinical trial in the last 1 month.
3. Subject doesn't agree to sign an informed consent from prior to study procedures.
4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
5. New York Heart Association (NYHA) Class IV heart failure.

Primary outcomes:
measure: All-cause death
timeFrame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
measure: Composite of ischemic stroke, thromboembolism and all death
timeFrame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Ping Li, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01760369: Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
Official title: Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Cerebral Oxygen Saturation During Head Rotation
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital, Copenhagen.

Brief summary: The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.


Eligibility criteria: Inclusion Criteria:

* Lower back surgery
* Age \[18-80\]
* ASA group I-III
* free and painless movement of the neck (including flexion, extension and rotation)

Exclusion Criteria:

* Pain during neck movement as mentioned under inclusion criteria.
* known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
* any stenosis of the carotid vessels or known symptoms associated with such
* BMI \> 35

Primary outcomes:
measure: Change in regional cerebral oxygenation (rSO2)
timeFrame: 1 day
Secondary outcomes:
measure: Post anesthetic complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Glostrup Hospital
state: Glostrup kommune
Study officials:
affiliation: Doctor
name: Johnny DH Andersen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen JD, Baake G, Wiis JT, Olsen KS. Effect of head rotation during surgery in the prone position on regional cerebral oxygen saturation: A prospective controlled study. Eur J Anaesthesiol. 2014 Feb;31(2):98-103. doi: 10.1097/EJA.0000000000000028.