louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04270344: The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment
Official title: A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypercholesterolemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 905
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypercholesterolemia and AMI

Brief summary: Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

Detailed description: Following subjects with AMI event within 1 month will be assessed MACE event for 1year

* Essential hypertension or heart failure
* Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
* Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),

Eligibility criteria: Inclusion Criteria:

* idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
* diagnosed AMI (STEMI, NSTEMI) 1 months ago
* more than 19 years old and more than 2 years of life expectancy at screening
* informed consent

Exclusion Criteria:

* cardiogenic shock or corresponding clinical events
* contraindicated to the IP
* unsuitable to this study judged by investigators

Primary outcomes:
measure: all-cause mortality, non-fatal MI, repeat re-vascularization
timeFrame: 12 months
Secondary outcomes:
measure: The rate of mortality
timeFrame: 6 and 12 months
measure: The rate of cardiac death
timeFrame: 6 and 12 months
measure: The rate of nonfatal MI
timeFrame: 6 and 12 months
measure: The rate of hospitalization due to heart failure
timeFrame: 6 and 12 months
measure: The rate of Coronary artery bypass graft(CABG)
timeFrame: 6 and 12 months
measure: The rate of target lesion re-vascularization
timeFrame: 6 and 12 months
measure: The rate of target vessel re-vascularization
timeFrame: 6 and 12 months
measure: The rate of cerebrovascular disease
timeFrame: 6 and 12 months
measure: The change of SBP, DBP
timeFrame: 6 and 12 months
measure: The change of TC, TG, HDL-C, LDL-C, hsCRP
timeFrame: 6 and 12 months
measure: The change of HbA1c, FBS
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: JWP
state: Seocho-gu
Study officials:
affiliation: Chonnam National University Hospital
name: Myungho Jeong, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05813444: Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors : a Cross-sectional Study
Official title: Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingival Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental student with healthy and intact periodontium

Brief summary: Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.


Eligibility criteria: Inclusion Criteria:

* age (18 years old or older)
* dental student on the university hospital of Nice
* social security affiliate
* systemically healthy
* healthy and intact periodontium
* informed consent.

Exclusion Criteria:

* pregnancy
* under any regular medical treatment
* active periodontal disease
* presence of plaque
* enduring orthodontic treatment
* periodontal surgery in the mandibulary anterior region
* non consent patient
* patient under judgment trials.

Primary outcomes:
measure: Gingival phenotype prevalence
timeFrame: 18 months
Secondary outcomes:
measure: Associated risk factors for thin gingival phenotype
timeFrame: 18 months
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
Study officials:
References:
Clinical trial NCT00743444: TLESR-impedance Study in Patients
Official title: A Double-blind, Placebo Controlled, Randomized, Two Centre Phase IIA Pharmacodynamic Cross-over Study to Assess the Effect of AZD3355, 65 mg Bid, on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in GERD Patients With an Incomplete Response to PPI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reflux Episodes
Keywords: GERD
transient lower esophageal sphincter relaxations (TLESRs)
reflux
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.


Eligibility criteria: Inclusion Criteria:

* Provision of written consent
* GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
* 6 months history of GERD and incomplete response to PPI treatment

Exclusion Criteria:

* Insufficient symptom burden of the reflux disease evaluated by questionnaires
* S-creatinine \>1.2 times upper limit of normal
* History of heart disease
* Prior surgery of the upper GI tract

Primary outcomes:
measure: Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose
timeFrame: 0-3 hours post meal, post third dose
Secondary outcomes:
measure: Total Number Reflux Episodes 0-24 Hours Post First Dose
timeFrame: 0-24 hours
measure: Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.
timeFrame: 0-12 hours post first dose
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Eva Ersdal, PhD
role: STUDY_DIRECTOR
affiliation: Center for Gastroenterological Research, Belgium
name: Daniel Sifrim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boeckxstaens GE, Beaumont H, Mertens V, Denison H, Ruth M, Adler J, Silberg DG, Sifrim D. Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease. Gastroenterology. 2010 Aug;139(2):409-17. doi: 10.1053/j.gastro.2010.04.051. Epub 2010 May 5.
Clinical trial NCT03960944: An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
Official title: Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Disturbance
Anxiety Disorder of Childhood
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Arsha Vidya Study Centre
name: United Research International
First posted: 2019-05-23
Enrollment: 102
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Poverty is a common experience for many children and families in developing countries. Living in a poor or low-income household has been linked to poor health and increased risk for mental health problems than the general population. Previous studies link psychological well-being with yoga in adolescents and children. This study investigated the effects of a structured yoga program on psychological well-being in low-income school children.


Eligibility criteria: Inclusion Criteria:

* Low income Group
* Parental consent to participate in study

Exclusion Criteria:

* Disabilities
* Substance abuse
* Living outside the school areas

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Depression
timeFrame: Changes from baseline to 8 weeks
measure: Self Esteem
timeFrame: Changes from baseline to 8 weeks
Other outcomes:
Locations:
city: Mumbai
country: India
facility: NMP Medical Research Institute
state: Maharashtra
city: Jaipur
country: India
facility: United Research International
state: Rajasthan
city: Chennai
country: India
facility: Arsha Vidya Study Centre
state: Tamilnadu
Study officials:
affiliation: Arsha Vidya Study Centre, India
name: Buddhatmananda Saraswati
role: STUDY_CHAIR
affiliation: United Research International, India
name: Divya Gaur
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute, India
name: Rajubhai P Odedra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00330044: Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer
Official title: A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inoperable Non Small Cell Lung Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-05-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Detailed description: To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.

To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Eligibility criteria: Inclusion Criteria:

* Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

Exclusion Criteria:

* Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

Primary outcomes:
measure: Response and Progression Free Survival
timeFrame: Up to five years after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Maria Werner-Wasik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06935344: Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction: the PROVE Study
Official title: Evaluation of Polygenic Risk Score for Epithelial OVarian cancEr Risk Prediction and Clinical Outcomes in an Italian Population: the PROVE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Keywords: polygenic risk score
ovarian cancer
case-control
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases and controls enrolment will be conducted in the ovarian cancer and rheumatology outpatient clinics of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, respectively.

Brief summary: The goal of this observational study is to evaluate whether polygenic risk score (PRS) assessment can help predict the onset of epithelial ovarian cancer in women aged over 18, comparing those with a histologically confirmed diagnosis of epithelial ovarian or fallopian tube cancer (cases) to women with no personal history of ovarian cancer (controls). The main questions it aims to answer are:

* Is there an association between PRS and the presence of epithelial ovarian cancer?
* Can PRS improve the prediction of ovarian cancer risk when adjusted for other clinical factors?

Researchers will compare PRS values between cases and controls to see if higher PRS percentiles are associated with an increased risk of ovarian cancer.

Participants will:

* Complete a questionnaire on socio-economic status, lifestyle, and dietary habits.
* Undergo blood sampling, for the analysis of BRCA1-2, PALB2, RAD51C, RAD51D pathogenic variants.
* Undergo PRS analysis.


Eligibility criteria: Inclusion Criteria:

* For cases: women with a first-time diagnosis of histologically confirmed epithelial ovarian or fallopian tube cancer.
* For Controls women with no concomitant or past OC diagnosis.

Exclusion Criteria:

* For both cases and controls: the presence of concurrent malignancies other from OC.

Primary outcomes:
measure: Odds of developing EOC by different PRS percentiles
timeFrame: At enrollment
Secondary outcomes:
measure: Correlation of PRS percentiles and covariates
timeFrame: At enrollment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
state: Italia
Study officials:
References:
Clinical trial NCT01880944: Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study
Official title: Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: spine
trauma
MRI
contrast
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-06-19
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 patients that fulfilled the following criteria

Brief summary: Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma.

However, the role of contrast enhancement has not investigated in patients with spinal trauma.

Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically.

The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.


Eligibility criteria: Inclusion Criteria:

1. Patients who provided the informed consent
2. Patients with spinal trauma
3. Patients with age of 19 years or more

Exclusion Criteria:

1. Relative contraindication of MR contrast

   * previous history of any adverse event after injection of magnetic resonance contrast
   * pregnant or breast-feeding state
   * within 2 weeks after liver transplantation
   * epileptic disorder
2. Patients impossible with follow-up period of at least 2 months clinically
3. Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 and/or on dialysis
4. patients with age less than 19 years

Primary outcomes:
measure: The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
timeFrame: 2 months
measure: Confidence level
timeFrame: 2 months
Secondary outcomes:
measure: Diagnostic accuracy of non-enhanced and enhanced MRI
timeFrame: 2 months
measure: Inter- and intra-reader agreement of confidence level
timeFrame: 2 months
Other outcomes:
measure: Prognostic value of enhanced MRI
timeFrame: 2 months
measure: The rate (%) of change of treatment plan
timeFrame: 2 months
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Guen Young Lee
state: Gyenggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Guen Young Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246944: Induced Membrane Properties in Children and Adults
Official title: Induced Membrane Properties in Children and Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Loss
Surgery
Keywords: induced membrane
critical size defect
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.


Eligibility criteria: Inclusion Criteria:

* All patients treated at CHU Amiens-Picardie for bone critical sized defect treated using the induced membrane reconstruction technique.
* patients from 9 months to 60 years old

Exclusion Criteria:

* Patients managed by another reconstruction technique for critical sized defect
* Patients under guardianship, curators or deprived of liberty.
* Pregnant and nursing women.
* Patients who refused to participate in the study and to sign informed consent.

Primary outcomes:
measure: Measure of the BMP2 concentration of the induced membrane by immunodetection
timeFrame: one year (one year from day of surgery)
Secondary outcomes:
measure: BMP2 concentration of the induced membrane implanted in adults measured by immunodetection
timeFrame: one year (one year from day of surgery)
measure: BMP2 concentration of the induced membrane implanted in children measured by immunodetection
timeFrame: one year (one year from day of surgery)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Céline Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097092: Strength Training Augmenting Rehabilitation
Official title: Strength Training Augmenting Rehabilitation - 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Disuse Atrophy
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 20
Sex: ALL
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 project aims to determine whether a novel strength training rehabilitation protocol can diminish the negative consequences of limb immobilization and expedite the restoration of muscle function during retraining in healthy individuals.

Detailed description: The present study will examine the time course of muscle strength and size adaptations in two groups of volunteers during immobilization and retraining. Both groups will undergo temporary muscle disuse by wearing a shoulder sling and swathe on their non-dominant arm for \~≥10 hours/day for four weeks. One group (immobilization + unilateral training) will perform progressive unilateral strength training of the free limb throughout the immobilization period. The other group (immobilization control) will not undergo any training during the immobilization period. Following immobilization, both groups will undergo four weeks of bilateral strength training to retrain the immobilized arm.

Eligibility criteria: Inclusion Criteria:

* a body mass index between 18 - 35 kg/m2
* 18-35 years of age
* right-hand dominant
* willingness to comply with the immobilization requirements
* willingness to refrain from strength training outside of the study
* willingness to comply with the strength training procedures of the study

Exclusion Criteria:

* a personal or family history of blood clots
* a personal or family history of thyroid disorders
* previous orthopedic surgeries to the upper limbs and/or joint pain of the upper limbs in the last 6 months
* neuromuscular or metabolic disorders
* osteoarthritis
* use of hormone replacement therapy (ie., testosterone, estrogen, and/or growth hormone pharmaceuticals)
* pregnancy and/or nursing

Primary outcomes:
measure: Changes in isometric muscle strength
timeFrame: Changes from baseline at 5 and 10 weeks
measure: Changes in dynamic muscle strength
timeFrame: Changes from baseline at 5 and 10 weeks
measure: Changes in muscle size
timeFrame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
measure: Changes in lean mass
timeFrame: Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks
measure: Changes in EMG amplitude
timeFrame: Changes from baseline at 5 and 10 weeks
measure: Changes in action potential amplitude
timeFrame: Changes from baseline at 5 and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: TCU Neuromuscular Physiology Laboratory
state: Texas
city: Fort Worth
country: United States
facility: TCU RIC
state: Texas
Study officials:
References: