louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06172179: Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
Official title: Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporotic Vertebral Fracture
Prediction Model
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 500
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: Older population with osteoporosis, who have undergone vertebral augmentation procedures due to osteoporotic vertebral fractures.

Brief summary: "Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."


Eligibility criteria: Inclusion Criteria:

1. Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
2. No history of high-energy trauma;
3. Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
4. Has undergone Percutaneous Vertebroplasty (PVA) treatment.

Exclusion Criteria:

1. Incomplete imaging or medical record data;
2. History of spinal surgeries other than PVA;
3. Pre-existing symptoms of spinal cord compression or nerve root injury;
4. Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
5. Chronic conditions like Kummell's disease or non-union of old fractures;
6. Concurrent vertebral burst fractures;
7. Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
8. History of violent trauma after PVA procedure.

Primary outcomes:
measure: secondary vertebral fractures
timeFrame: 2 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen memorial hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Chunhai Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766479: Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
Official title: Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasia
Keywords: Colorectal cancer
colorectal neoplasia
CT colonography
advanced neoplasia
colonoscopy
family history
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 844
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Background: Although subjects with first-degree relatives (FDR) with a history of colorectal cancer (CRC) are at increased risk for CRC, compliance to screening colonoscopy is suboptimal. Computed tomographic colonography (CTC) has been recognized as an alternative for CRC screening in average risk subjects, but less information is available on its performance in FDRs.

Aims: To prospectively assess the accuracy of CTC as a screening tool in FDRs using colonoscopy (OC) with segmental unblinding as reference standard.

Methods: Consecutive patients admitted with CRC diagnosis (index case, IC) were prospectively evaluated. Following the systematic identification of ICs with inherited predispositions to CRC, ICs who agreed to contact their FDRs ≥40 years old were included. Available FDRs were invited to undergo non-cathartic CTC, with OC the following day. Sensitivity/specificity/PPV/NPV of CTC was assessed for detecting subjects with any lesion ≥6 mm, ≥10 mm, and for advanced neoplasia ≥6 mm.


Eligibility criteria: Inclusion Criteria:

* Family history for CRC (first degree)
* Age \>40 years old

Exclusion Criteria:

* Contraindications to colonoscopy or CT colonography
* Pregnancy

Primary outcomes:
measure: Number of patients in whom colorectal polyps and colorectal neoplasia have been detected by CT colonography, by adopting colonoscopy as gold standard, as a measure of efficacy.
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Clinico humanitas
Study officials:
References:
Clinical trial NCT02810379: Video Consent Form Versus Written Consent Form for ERCP
Official title: Combination of Video and Written Information Provides the Patient With a More Comprehensive Level of Knowledge About Endoscopic Retrograde Cholangiopancreatography: Study Protocol for Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Consent Forms of ERCP
Keywords: informed consent
ERCP
video
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.


Eligibility criteria: Inclusion Criteria:

* All inpatients who will receive ERCP

Exclusion Criteria:

* under 18 years or more than 70 years
* pregnancy or breast-feeding women
* circulatory and respiratory disorders
* mental illness

Primary outcomes:
measure: time for informed consent practices before ERCP
timeFrame: 2 days
measure: time for extra explanation about ERCP
timeFrame: 2 days
Secondary outcomes:
measure: satisfaction degree about the informed consent practices
timeFrame: 2 days
Other outcomes:
measure: anxiety level after the informed consent practices
timeFrame: 2 days
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xia T, Zhu YB, Zeng YB, Chen C, Wang SL, Zhao SB, Su XJ, Wang D, Yao J, Li ZS, Bai Y. Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial. J Dig Dis. 2019 Dec;20(12):656-662. doi: 10.1111/1751-2980.12824. Epub 2019 Nov 21.
Clinical trial NCT06952179: Pericardial Histopathology and COVID-19 Seropositivity
Official title: Pericardial Histopathology and COVID-19 Seropositivity in Adult Patients Undergoing First-Time Coronary Artery Bypass Grafting: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Response
COVID-19
Pericardial Disease
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included adult patients (≥20 years) undergoing first-time isolated coronary artery bypass grafting (CABG). All patients had available pericardial tissue samples for histopathological evaluation and preoperative COVID-19 serological testing. Patients with prior cardiac surgery, active COVID-19 infection, systemic inflammatory diseases, chronic immunosuppressive therapy, or malignancy were excluded.

Brief summary: This prospective study aims to investigate the association between pericardial histopathologic inflammation grades (acute, chronic, or absent) and COVID-19 seropositivity in adult patients undergoing first-time isolated coronary artery bypass grafting (CABG). Pericardial tissue samples were collected during surgery and evaluated histopathologically, while preoperative COVID-19 serological testing was performed. The primary outcome is to determine whether COVID-19 seropositivity is associated with the severity of pericardial inflammation. Patients with prior cardiac surgery, active COVID-19 infection, systemic inflammatory diseases, chronic immunosuppressive therapy, or malignancy were excluded from the study.


Eligibility criteria: Inclusion Criteria:

* Age ≥20 years
* Undergoing first-time isolated coronary artery bypass grafting (CABG)
* Availability of pericardial tissue sample for histopathological analysis
* Preoperative COVID-19 serological testing performed
* Written informed consent obtained

Exclusion Criteria:

* Previous history of cardiac surgery (e.g., prior CABG, valve surgery)
* Concomitant cardiac procedures during the same operation (e.g., valve repair, aortic surgery)
* Active COVID-19 infection at the time of surgery (positive PCR test)
* Known autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis)
* Chronic immunosuppressive therapy (e.g., steroids, biologics)
* Known malignancy at the time of surgery

Insufficient or inadequate pericardial tissue sample for histopathological assessment

Primary outcomes:
measure: Pericardial inflammation histopatalogical evaluation
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University Faculty of Medicine
Study officials:
affiliation: samsun university Faculty of medicine
name: emrah ereren
role: STUDY_CHAIR
References:
Clinical trial NCT03537079: Hypoxic Conditioning in Heart Failure
Official title: Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: hypoxia
exercise training
heart failure
cardiac remodeling
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe

Detailed description: All heart failure patients will have a session of 45' of bicycle exercise training (in normoxia or hypoxia) AND a one hour rest session (in normoxia or hypoxia).

Exercise training sessions will consist in a continue bicycle exercise test at 70 to 80 % of the maximal heart rate, while breathing (single blind) normoxia or hypoxia gaz.

Rest conditioning consist in a one hour of rest, while breathing (single blind) normoxia or hypoxia gaz.

For hypoxia sessions, the oxygen saturation target will be fo 85-90 % for the 4 first weeks and 80-85 % for the last 4 weeks.

Three arms :

* exercise training in NORMOXIA and rest conditioning in NORMOXIA
* exercise training in HYPOXIA and rest conditioning in NORMOXIA
* exercise training in NORMOXIA and rest conditioning in HYPOXIA

Eligibility criteria: Inclusion Criteria:

* patient available for exercise training
* stable heart failure state I-II New York Heart Association (NYHA) with altered ejection fraction (EF ≤ 40 %)
* signed informed consent

Exclusion Criteria:

* unstable ischemic cardiopathy
* right ventricle dysfunction
* uncontrolled arrythmias
* rest elevated in pulmonary artery pressure (≥ 45 mmHg)
* migraine
* high altitude trip above 2500 m high during study period
* impossibility to realise a maximal bicycle exercise test

Primary outcomes:
measure: maximal oxygen uptake in ml/min/kg
timeFrame: after 8 weeks of training and conditioning
Secondary outcomes:
measure: End diastolic left ventricle diameter in mm
timeFrame: After 8 weeks of training and conditioning
measure: systolic left ventricle ejection fraction in %
timeFrame: After 8 weeks of training and conditioning
measure: flow mediated dilatation (FMD) in %
timeFrame: After 8 weeks of training and conditioning
measure: systolic and diastolic blood pressure control in mmHg
timeFrame: After 8 weeks of training and conditioning
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT02070679: Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stable Angina
Unstable Angina
Non ST Segment Elevation Myocardial Infarction
Post MI
Keywords: Alpha-tocopherol
Vitamin E
Contrast-Induced Acute Kidney Injury
Coronary angiography
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary angiography.


Eligibility criteria: Inclusion Criteria:

1. All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography.
2. Patients who have eGFR ≤60 ml/min/1.73 m2

Exclusion Criteria:

1. Allergy to contrast media
2. Cardiogenic shock
3. Pulmonary edema
4. Overt cardiac failure or left ventricular ejection fraction ≤ 30%
5. Acute kidney injury
6. The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days
7. The history of dialysis
8. Being pregnant
9. Having recent acute myocardial infarction
10. Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days

Primary outcomes:
measure: The development of CI-AKI in group receiving vitamin E compared with placebo
timeFrame: Within 72 hours after coronary angiography
Secondary outcomes:
measure: Changes in the serum level of Cr and the amount of eGFR
timeFrame: Within 72 hours
Other outcomes:
Locations:
city: Urmia
country: Iran, Islamic Republic of
facility: Seyyed-al-Shohada Heart Center, UMSU
state: West-Azerbaijan
city: Urmia
country: Iran, Islamic Republic of
facility: Taleghani Hospital, UMSU
state: West-Azerbaijan
Study officials:
References:
citation: Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.
Clinical trial NCT06018779: Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
Official title: Effectiveness of Cryo Plus Ultrasound Therapy Versus Diathermy in Combination With High-intensity Laser Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Physical Therapies
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in male professional soccer players with muscle injuries. The main questions it intends to answer are:

• Is this combination of treatments effective in these patients in terms of pain relief?

Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy and high intensity laser. Researchers will compare the group of participants, called the treatment group, with a control group to see if:

• Is the combined treatment of cryoultrasound therapy and high intensity laser more effective in these patients than the combination of diathermy and high intensity laser?


Eligibility criteria: Inclusion Criteria:

* age 18-21 years;
* professional footballer in a competitive club;
* presence of a grade III A muscle lesion, according to the Mueller-Wohlfart classification, confirmed by ultrasound examination and occurring during sports activity at least 5 days before inclusion in the present study;
* no previous muscle injuries in the last 6 months;
* signature of the written informed consent for participating in the study.

Exclusion Criteria:

* previous muscle injuries or bone fractures of the lower limbs in the last 6 months;
* knee instability due to previous rupture of knee ligaments;
* active neoplastic or infectious diseases;
* congenital anomalies of the lower limbs.

Primary outcomes:
measure: entity of the pain
timeFrame: 2 weeks
Secondary outcomes:
measure: size of the muscle tear
timeFrame: 2 weeks
measure: frequency of relapses
timeFrame: 3 months after the injury
measure: return to play
timeFrame: 3 months after the injury
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
References:
Clinical trial NCT00762879: Spine Quantitative Computed Tomography (QCT)
Official title: Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile Idiopathic Arthritis
JIA
Arthritis
Osteoporosis
Osteoporosis in Children
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 127
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 control patients and 30 study patients

Brief summary: The purpose of this study is to compare healthy children to children who have a chronic illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16 and younger.

Detailed description: Children with chronic illnesses are at risk for bone fragility due to inflammation, glucocorticoid therapy, physical activity limitation, malnutrition, and pubertal delay. The impact of low bone mass during childhood may be immediate, resulting in childhood fractures, or delayed, due to suboptimal peak bone mass attainment.

Eligibility criteria: Inclusion Criteria:

* for JIA patients: subjects age 5-21 Drawn from Dr. Burnham's prospective cohort study of bone health in 101 children with arthritis.
* for Control patients: subjects age 5-21 Controls will be a 50% male/female

Exclusion Criteria:

* for JIA patients: Subjects with JIA will be excluded if they have conditions or drug exposure unrelated to JIA and known to impact growth or bone health.
* for Control patients: Chronic disease or syndrome known to affect growth or bone health, prematurity (\<37 weeks gestation), or use of any medication known to affect growth.

Primary outcomes:
measure: Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage.
timeFrame: same day
Secondary outcomes:
measure: Children with JIA will have lower vertebral stiffness and strength, compared with controls.
timeFrame: same day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jon Burnham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02464579: Breastfeeding Rates at the Department of Neonatology of University Hospital Cologne
Official title: Prospective Inquiry of Breastfeeding Success at the Department of Neonatology of University Hospital of Cologne and Analysis of Influencing Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn
Keywords: breastfeeding rate
preterm infant
neonatal intensive care unit
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 450
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patients of the Department of Neonatology of Cologne.

Brief summary: The objective of this study is to measure the breastfeeding success for all preterm and term newborns in our department of neonatology during the hospital stay and at the age of six months.

Detailed description: A score was established which combines information on breastfeeding rate and breastmilk feeding rate, and used to monitor daily breastfeeding success.

Eligibility criteria: Inclusion Criteria:

* Inborn or referred to our Department of Neonatology in the first week of life
* Informed consent of both parents or legal guardian

Exclusion Criteria:

* No informed consent of parent or legal guardian.

Primary outcomes:
measure: Breastfeeding Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Neonatology at University Hospital of Cologne
Study officials:
affiliation: Neonatology at the University Hospital of Cologne
name: Titus Keller, MD
role: PRINCIPAL_INVESTIGATOR
References: