louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01907425: Prenatal Molecular Characterisation by CGH+SNP-ARRAY of Supernumerary Marker Chromosomes and de Novo Apparently Balanced Reciprocal Translocations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-natal Patient
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently balanced reciprocal translocations are revealed by foetal karyotyping, which does not always make it possible to determine whether the anomaly is balanced or not and does not reveal uniparental disomy. The presence of these chromosomal rearrangements raises a difficult question for genetic counselling during pregnancy because of the risk of intellectual deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced or not nature of these translocations 2) the presence or not of euchromatin in the SMC 3) the presence or not of uniparental disomy.


Eligibility criteria: Inclusion Criteria:

* Metaphase karyotyping with SMC or a de novo Apparently-balanced reciprocal translocation
* Parents covered by the National Health Insurance Agency,
* Consent of the parents

Exclusion Criteria:

* Persons not covered by the National Health Insurance Agency
* Normal foetal karyotyping or showing chromosomal anomalies not related to the present study (trisomy 18....) or inherited anomalies
* Absence of a sample from one of the parents

Primary outcomes:
measure: supernumerary chromosome markers
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT03281525: Sleep Quality Underwent Heart Transplant, an Observational Study
Official title: Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Dysfunction
Keywords: cardiotransplant
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD

Brief summary: The SQ_Heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98 Cardiotransplant patients.

Detailed description: The Primary objective of the SQ_Heart study is to evaluate the significant difference in sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of \> 5 for poor sleepers.

Patients, to be enrolled, must provide:

* Age ≥ 18 and \< 90;
* Cardiotransplant patients, with VAD or non;
* patients with VAD.
* subjects able to sign informed consent.

All the patients will have to complete some questionnaires:

* questionnaire about the diagnosis of pathology and lifestyle;
* questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep Quality (PSQI);
* questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L).

Questionnaires are necessary for the data collection for the study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and \< 90;
* Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
* patients with VAD ;
* subjects able to sign informed consent.

Exclusion Criteria:

* Age \< 18;
* subjects don't sign informed consent;
* hospitalization for more than 30 days before compilation in intensive care unit.

Primary outcomes:
measure: Sleep Quality Index
timeFrame: up 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
References:
Clinical trial NCT00361725: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients With Organ Failure
Official title: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Sepsis
Organ Failure
Keywords: severe sepsis
organ failure
activated protein C
thrombomodulin
EPCR
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.

The only intervention is a venous blood sampling at the onset of the disease.

The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.

Detailed description: analysis of the PC pathway

* PC activity
* PS activity
* soluble thrombomodulin
* soluble EPCR
* activated protein C
* quantitative flow cytometry on monocytes (thrombomodulin and EPCR)
* whole blood mRNA (Tissue factor, thrombomodulin and EPCR)
* inflammatory gene expression analysis by MLPA

Eligibility criteria: Inclusion Criteria:

* severe sepsis patients or:
* non-septic acute organ failure patients or:
* healthy subjects matched for age and sex with severe sepsis patients

Exclusion Criteria:

* criteria for organ failure lasting for more than 24 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Luc DIEHL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgel D, Clauser S, Bornstain C, Bieche I, Bissery A, Remones V, Fagon JY, Aiach M, Diehl JL. Elevated growth-arrest-specific protein 6 plasma levels in patients with severe sepsis. Crit Care Med. 2006 Jan;34(1):219-22. doi: 10.1097/01.ccm.0000195014.56254.8a.
citation: Borgel D, Bornstain C, Reitsma PH, Lerolle N, Gandrille S, Dali-Ali F, Esmon CT, Fagon JY, Aiach M, Diehl JL. A comparative study of the protein C pathway in septic and nonseptic patients with organ failure. Am J Respir Crit Care Med. 2007 Nov 1;176(9):878-85. doi: 10.1164/rccm.200611-1692OC. Epub 2007 Aug 2.
Clinical trial NCT04872725: The Effect of Covid-19 Process
Official title: The Effect of Covid-19 Process on Time Management, Participation and Leisure Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Participation, Patient
Keywords: Covid-19
leisure time activities
participation
time management
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged between 18-65, signed "Informed Consent Form" and fulfilled the inclusion criteria

Brief summary: Objective: The purpose of this study was to investigate the effect of the Covid-19 process on time management, participation, and leisure time activity.

Methods: 531 individuals aged between 18-65 were included in the study. The individuals were evaluated with the Assessment Of Time Management Skills (ATMS) in terms of time management, with the Social Isolation Questionnaire (SIQ) in terms of participation, and with the Interest Checklist (IC) in terms of leisure time activities.


Eligibility criteria: Inclusion Criteria:

* aged between 18-65
* lived the Covid-19 process in Turkey

Exclusion Criteria:

* did not complete the scales
* did not live in Turkey

Primary outcomes:
measure: Assessment of Time Management Skills
timeFrame: from March to June
measure: Social Isolation Questionnaire
timeFrame: from March to June
measure: Interest Checklist
timeFrame: from March to June
Secondary outcomes:
Other outcomes:
Locations:
city: Beykoz
country: Turkey
facility: Istanbul Medipol University
state: İstanbul
Study officials:
affiliation: Medipol University
name: Miray BUDAK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01846325: The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthenozoospermia
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 180
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.


Eligibility criteria: Inclusion criteria:

* Willing to participate in the study and filling out the informed consent form
* should be infertile (no conception after 12 months intercourse without any contraception)
* age 20-45 y.o, idiopathic asthenospermia according to WHO criteria
* normal hormonal profile

Exclusion criteria:

* any infection in genitourinary (GU) tract
* any anatomical abnormality in GU tract
* any chronic disease during last 3 months
* any surgery in GU tract
* consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months

Primary outcomes:
measure: sperm motility
timeFrame: 12 weeks
Secondary outcomes:
measure: sperm count
timeFrame: 12 weeks
measure: seminal oxidative stress
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Eslamian G, Amirjannati N, Noori N, Sadeghi MR, Hekmatdoost A. Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):707-719. doi: 10.1093/ajcn/nqaa124.
Clinical trial NCT00512148: Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Official title: An Open Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neurogenic Bladder
Lead sponsor: Tengion
Sponsor class: INDUSTRY
First posted: 2007-08-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Primary purpose: TREATMENT

Brief summary: Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum detrusor pressure.


Eligibility criteria: Inclusion Criteria:

* subjects with neurogenic bladders secondary to spinal cord injury

Exclusion Criteria:

* prior augmentation procedures or urinary diversion
* recent urologic or intraperitoneal surgery or device implantation
* recent history of spinal cord injury of less than a year
* recent neurologic surgery
* requirement for concomitant urological surgical procedures

Primary outcomes:
measure: Change in Maximum Detrusor Pressure From Baseline to 12 Months
timeFrame: baseline and 12 months
measure: Overall Safety Profile - Number of Participants Experiencing an Adverse Event
timeFrame: through month 12
Secondary outcomes:
measure: Urodynamic Measurements and Long Term Safety
timeFrame: month 12 through month 60
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Tengion, Inc
name: Sunita Sheth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02761148: The Relationship Between White Matter Hyperintensity With Cognition and Emotion
Official title: The Relationship Between White Matter Hyperintensity With Cognition and Emotion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aged
Leukoaraiosis
Keywords: white matter hyperintensity
brain network
MRI
cognition
emotion
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged patients with white matter hyperintensity

Brief summary: White matter hyperintensity (WMH) has been found to be related with cognitive and emotional dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a large-scale brain network, thereby impairing the brain's ability to integrate the neural processes efficiently. It is not yet clear, what the pattern of brain network disruption relates to WMH and how the brain network disruption induced by WMH has an effect on cognition and emotion performance. Using multi-model magnetic resonance imaging (MRI) techniques, we aimed to explore the mechanisms of cognitive decline and depression related with brain network dysfunction in patients with WMH, and to provide objective imaging marker for early diagnosis and prevention of WMH associated cognitive decline and depression.


Eligibility criteria: Inclusion criteria:

1. white matter hyperintensity visible on T2 fluid-attenuated inversion recovery images;
2. age between 35 to 80 years;
3. without stroke lesion (except lacunar infarction) on current diffusion weighted images;
4. without a history of multiple sclerosis, Alzheimer's disease, Parkinson's disease and head trauma.

Exclusion criteria:

1. white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
2. intracranial hemorrhage;
3. with severe head motion on magnetic resonance images

Primary outcomes:
measure: Fazekas Scale of white matter hyperintensity
timeFrame: 1 year
measure: Mini-Mental State Examination (MMSE)
timeFrame: 1 year
measure: Hamilton Depression Scale (HAMD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,
state: Zhejiang
Study officials:
References:
Clinical trial NCT03989648: Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty
Official title: Comparison of the Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Minimally Invasive Total Knee Arthroplasty : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esmarch Bandages
Simple Leg Elevation
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee

Exclusion Criteria:

* There are deep vein thrombosis and pulmonary embolism
* There are bleeding disorder,hypercoagulability,peripheral arterial disease and chronic venous insufficiency
* Take blood clotting pills
* Have had total knee arthroplasty
* BMI \> 30

Primary outcomes:
measure: Fromme-Boezaart surgical field scale
timeFrame: Immediate after surgery
Secondary outcomes:
measure: Numerical rating scale: NRS at 24 hrs
timeFrame: 24 hours after surgery
measure: Numerical rating scale: NRS at 72 hrs
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331548: Endobronchial Ultrasound Transbronchial Needle Aspiration Of Enlarged Mediastinal In Interstitial Lung Disease
Official title: Study Of Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Cytology Of Enlarged Mediastinal & Hilar Lymph Nodes Detected In Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center

Brief summary: The aim of this study is to assess the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis interstitial lung disease ( ILD) who demonstrate LN enlargement on chest imaging. Patients with non-sarcoidosis ILD referred for bronchoscopy will undergo LN sampling by EBUS-TBNA. Cytology results will be recorded along with clinico-radiologic features, BAL findings, histology and final ILD diagnosis.


Eligibility criteria: Inclusion Criteria:

1. non-sarcoidosis ILD (low probably of sarcoidosis based on radiology),
2. referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center
3. Patients with LN enlargement ≥1 cm in short diameter at stations 2, 4, 7, 10 or 11 (LN stations accessible to EBUS-TBNA)

Exclusion Criteria:

1. known ILD
2. ILD with no indication to bronchoscopy
3. contraindication to bronchoscopy .

Primary outcomes:
measure: assessing the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis ILD who demonstrate LN enlargement on chest imaging.
timeFrame: during the procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04684030: The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
Official title: The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group.
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients ages \>= 20 years
2. Patients diagnosed with type 1 diabetes.
3. Patients with glycated hemoglobin (HbA1c) \> 8.0% within 6 months before screening
4. Patients who agree to perform self blood glucose monitoring responsibly during the study period
5. Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment

Exclusion Criteria:

1. Patients diagnosed with type 2 diabetes.
2. Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
3. Patients who cannot use the device properly such as an illiterate person or foreigners
4. Patients incapable of making decisions based on their own judgement and will
5. A person who may not participate in the study according to investigator's judgement

Primary outcomes:
measure: The change of glycated hemoglobin (HbA1c) level
timeFrame: 12 weeks after applying continuous glucose monitoring system
Secondary outcomes:
measure: The number of participants with improved clinical glycometabolic parameters
timeFrame: 12 weeks after applying continuous glucose monitoring system
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Diabetes Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital Diabetes Center
name: EunSeok Kang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01803230: Creatine Supplementation on Cognition in Children
Official title: Effects of Creatine Supplementation on Cognitive Function in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: children
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.


Eligibility criteria: Inclusion Criteria:

* healthy children
* age between 10 to 12 years of age

Exclusion Criteria:

* cognitive impairment
* vegetarian diet
* use of creatine in the past 6 months
* chronic kidney disease

Primary outcomes:
measure: cognitive function
timeFrame: 7 days
Secondary outcomes:
measure: tissue creatine content
timeFrame: 7 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References: