louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06060769: Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging
Official title: Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis； Tumor
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease who may develop liver cancer.

Brief summary: Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.

Detailed description: Retrospectively and prospectively collect T1 mapping, T2 mapping, T2\* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.

Eligibility criteria: Inclusion Criteria:

* 1. Aged over 18 years old; 2. Liver function Child-Pugh classification A or B; 3. Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)"; 4. Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2\* mapping, T1ρ and other sequences; 5. With 5-year follow-up data.

Exclusion Criteria:

* 1. Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.; 2. Patients who have undergone liver surgery in the past; 3. Patients with major diseases such as heart failure and tumors.

Primary outcomes:
measure: HCC incidence rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Yaqin, Zhang
state: Guangdong
Study officials:
affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Yaqin Zhang, MD, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT04496869: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment
Official title: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility Treatment
Women
Keywords: psychological response
infertility treatment
lockdown period
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 435
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 42 years and 12 months, followed in the infertility Center of Femme Mère Enfant Hospital (HFME - Bron - France).

Brief summary: In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population.

Some recent studies have looked at the relationship between anxiety and depression in ART cares.

Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men.

First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%.

With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.


Eligibility criteria: Inclusion Criteria:

* Consulting the center between 01/01/2020 to 12/31/2020
* Email address in the medical records
* All causes of infertility

Exclusion Criteria:

* Women followed for:
* Preservation of fertility
* Oocyte donation
* Women who do not speak or read French

Primary outcomes:
measure: Psychological impact assessed by scores of PSS10 scales.
timeFrame: baseline
measure: Psychological impact assessed by scores of HADS scales.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT06604169: An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
Official title: An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HCM - Hypertrophic Cardiomyopathy
S-ICD System (implantable Defibrillator)
Keywords: HCM
S-ICD
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 589
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was a multicenter, prospective, observational study that prospectively included HCM patients assessed as meeting the ICD implantation indication at Fuwai Hospital and National Collaborative Hospitals from July 1, 2024 to June 30, 2027.

Brief summary: 1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD.
2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.

Detailed description: The study was a multicenter, prospective, observational study that prospectively included HCM patients assessed as meeting the ICD implantation indication at Fuwai Hospital and National Collaborative Hospitals from July 1, 2024 to June 30, 2027, for pre-operation screening of S-ICD, and follow-up of patients eventually implanted with S-ICD.

Eligibility criteria: Inclusion Criteria:

* HCM patients assessed as meeting the ICD implantation indication

Exclusion Criteria:

* Combined with bradycardia with pacing indications;
* Frequent monomorphic ventricular tachycardia require ATP therapy;
* With indications of CRT;
* Combined with other diseases, life expectancy is less than 1 year.

Primary outcomes:
measure: the failure rate of S-ICD screening
timeFrame: 3 months
measure: The inappropriate shock event
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
References:
Clinical trial NCT05237869: Blood Flow Restriction & Tennis Elbow Rehab
Official title: Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 250
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: Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.


Eligibility criteria: Inclusion Criteria:

1. Ages 18-65 years of age
2. Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound
3. Must be able to read and write in English
4. Able to provide own written consent

Exclusion Criteria:

1. Patients over 65 years of age
2. Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10
3. History of prior injection for treatment of lateral epicondylitis
4. Pregnancy
5. Recent history of deep venous thrombosis (within the past 12 months)
6. Active treatment with anticoagulants
7. History of upper quadrant lymph node dissection
8. History of endothelial dysfunction
9. Patient history of easy bruising
10. Active infection in the injured arm
11. Cancer
12. Uncontrolled peripheral vascular disease
13. Uncontrolled diabetes mellitus

Primary outcomes:
measure: Define the effect of BFR training on pain with activity in patients with LE.
timeFrame: 3 weeks to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Vicki Jones
state: Missouri
Study officials:
affiliation: University of Missouri Department of Orthopaedic Surgery
name: Julia Nuelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027869: Normal Brain Imaging Database for Brain Disorder Studies
Official title: Normal Brain Imaging Database for Brain Disorder Studies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.


Eligibility criteria: Inclusion Criteria:

* N/A

Exclusion Criteria:

* History of any neurological or psychiatric diseases;
* Abnormal MRI;
* metal implants or a cardiac pacemaker;
* Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
* severe hypertension.
* cardiovascular disease.
* Family history of epilepsy.

Primary outcomes:
measure: functional connectivity
timeFrame: immediate (less than 30 minutes)
Secondary outcomes:
measure: Stroop task performance
timeFrame: immediate (less than 60 minutes)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT00394069: PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
Official title: A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiolitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.


Eligibility criteria: Inclusion Criteria :

* Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms

Exclusion Criteria :

* A history of any significant illness that will pose additional risk to the patient

Primary outcomes:
measure: To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.
timeFrame: 14 days
Secondary outcomes:
measure: To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months.
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Knorr B, Maganti L, Ramakrishnan R, Tozzi CA, Migoya E, Kearns G. Pharmacokinetics and safety of montelukast in children aged 3 to 6 months. J Clin Pharmacol. 2006 Jun;46(6):620-7. doi: 10.1177/0091270006288324.
Clinical trial NCT02214069: Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation
Official title: Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: AliveCor
First posted: 2014-08-12
Enrollment: 60
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 admitted to the hospital for your atrial fibrillation or atrial flutter

Brief summary: The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

Detailed description: AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.

Eligibility criteria: Inclusion Criteria:

1. Male or female between \> 18 and \< 80 years of age
2. Paroxysmal or persistent atrial fibrillation
3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
5. Willing to use the Alive Cor case
6. Written informed consent

Exclusion Criteria:

1. Unable or unwilling to use the Alive Cor case for their smart phone
2. Presence of a permanent pacemaker

Primary outcomes:
measure: Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation
timeFrame: 6 month
Secondary outcomes:
measure: Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Khaldoun Tarakji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.
Clinical trial NCT00153569: Multiepitope Peptide Vaccination in Melanoma
Official title: Phase II Study of Multiepitope Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Melanoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial assesses the clinical efficacy of a multiepitope peptide vaccine with GM-CSF and KLH as immunological adjuvants in stage IV melanoma patients


Eligibility criteria: Inclusion Criteria:

* Metastatic melanoma
* HLA-A1, -A2, -A24, -B44

Exclusion Criteria:

Primary outcomes:
measure: Clinical efficacy
Secondary outcomes:
measure: Immune response
measure: Safety
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hem&Onc Charité CBF
Study officials:
affiliation: Charité, CBF
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheibenbogen C, Schadendorf D, Bechrakis NE, Nagorsen D, Hofmann U, Servetopoulou F, Letsch A, Philipp A, Foerster MH, Schmittel A, Thiel E, Keilholz U. Effects of granulocyte-macrophage colony-stimulating factor and foreign helper protein as immunologic adjuvants on the T-cell response to vaccination with tyrosinase peptides. Int J Cancer. 2003 Mar 20;104(2):188-94. doi: 10.1002/ijc.10961.
Clinical trial NCT05395169: EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Official title: EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Tension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis:

There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome.

Statement of the problem:

Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?

Detailed description: For some women, symptoms of PMS may be so severe that they miss work or school. Physical activity is a suitable method for the treatment of PMS and is the best method for all women to reduce pressure and balance the brain's chemical secretion. It seems that physical activity by increasing endorphins and reducing adrenal cortisol leads to the improvement of symptoms of PMS.

DASH diet has been suggested to play an important role in the development, and treatment of some psychological disorders. For instance, it has been reported that a diet rich in fish, folate, and B-vitamins can alleviate the manifestations of depression. An established association was also shown between the dietary glycemic index (GI) and psychological diseases, depressive disorder, and mental functioning.

Diets containing of "junk foods" (high energy and low nutritional) have been shown to increase the risk of mental illness, but a healthy diet is associated with less depressive symptoms and can improve mood .

Eligibility criteria: Inclusion Criteria:

* Fifty adolescent females were diagnosed with premenstrual syndrome.
* Their age will be ranged from 15-to 25 years (3 years post-puberty).
* Their body mass index (BMI) will range from 18-25.9 kg/m2.
* All are of regular menstrual cycles.
* All of them suffer from moderate and severe PMS.

Exclusion Criteria:

* Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
* Having irregular menstruation.
* Any metabolic diseases.
* Any history of gynecological intervention.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: assessment will be take 12 weeks
measure: Menstrual Distress Questionnaire (MDQ)
timeFrame: assessment will be take 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05103969: Cohort of Tumors With POLE/D1 Mutation
Official title: Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumors
POLE Exonuclease Domain Mutation
POLD1 Gene Mutation
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 100
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: - Patient with a histologically proven tumor with a POLE or POLD1 mutation identified by molecular biology analysis, carried out within the framework of clinical practice in the platforms that have set up this research.

Brief summary: Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined

Detailed description: The identification of patients to be included will be done directly from the tumor genotyping platforms.

Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.

The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.

The diagnostic and follow-up data of each patient will be collected prospectively.

Eligibility criteria: Inclusion Criteria:

* Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).
* Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).

Diagnosis made from the date of launch of the cohort and in the previous year

-Age ≥ 18 years

Exclusion Criteria:

* Tumor without POLE or POLD1 mutation
* Tumor with POLE mutation identified in research studies retrospective research
* Opposition of the patient to the registration of his data in the cohort

Primary outcomes:
measure: To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites
timeFrame: October 2027
measure: Molecular characterization of the identified POLE/POLD1 mutations
timeFrame: October 2027
measure: Overall survival and response to treatments
timeFrame: October 2027
Secondary outcomes:
measure: database and block librabry
timeFrame: October 2027
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU -hopital Rangeuil
Study officials:
affiliation: Fédération francophone de Cancérologie digestive
name: Rosine GUIMBAUD, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References: