louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06876883: MItral Regurgitation Risk Assessment and CLinical ModElling
Official title: MItral Regurgitation Risk Assessment and CLinical ModElling (MIRACLE Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Insufficiency
Mitral Regurgitation (MR)
Keywords: mitral regurgitation
all-cause mortality
clinical modelling
cardiovascular mortality
heart failure hospitalization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 2000
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: Adult patients diagnosed with ≥ moderate mitral regurgitation (MR) during hospitalization were enrolled.

Brief summary: Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality. According to causes, MR could be divided into primary or secondary MR. The risk factors of mortality or heart failure hospitalization in different types of MR patients are under intensive investigation.

MItral Regurgitation risk Assessment and CLinical modElling (MIRACLE) study is a prospective cohort study including adult patients diagnosed with ≥ moderate MR during hospitalization. We aim to evaluate the prognostic risk factors of patients with MR and construct a prognostic clinical model to guide clinical decision-making.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
* Aged over 18 yrs.

Exclusion Criteria:

* Patients unable to provide written consent.

Primary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: Through study completion, an average of 5 years
measure: Heart Failure Hospitalization (HFH)
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen Univerity
state: Guangdong
Study officials:
References:
Clinical trial NCT01136083: Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Official title: Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small-cell Lung Cancer
Keywords: Tumor
Angiogenesis
Exercise training
VEGF
Myostatin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2010-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on

1. circulating VEGF-A
2. muscle growth and function
3. Myostatin


Eligibility criteria: Inclusion Criteria:

* Age 40-75 years
* Advanced NSCLC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Targeted therapy for at least 8 weeks
* Stable condition

Exclusion Criteria:

* Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
* Do not understand the verbal or written instructions

Primary outcomes:
measure: Exercise capacity
timeFrame: 8 weeks after the start of the intervention
Secondary outcomes:
measure: Imaging of muscle
timeFrame: 8 weeks and 16 weeks after the start of the intervention
measure: Analysis of venous blood sample
timeFrame: 8 weeks andd 16 weeks after the start of the intervention
measure: Quality of life
timeFrame: baseline, 8 weeks, 16 weeks
measure: Exercise capacity
timeFrame: 16 weeks after the start of the intervention
measure: Muscle function
timeFrame: 8 weeks and 16 weeks after the start of the intervention
measure: Physical activity
timeFrame: 8 weeks andd 16 weeks after the start of the intervention
measure: Dietary intake
timeFrame: 8 weeks andd 16 weeks after the start of the intervention
measure: Body composition
timeFrame: 8 weeks andd 16 weeks after the start of the intervention
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01112397: Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours
Official title: A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Malignancies
Keywords: Jak2
cancer
jak 1
stat 3
Phase 1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 72
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 study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase
* ECOG Performance Status 0-1
* Evidence of post-menopausal status in females or males willing to use barrier contraception

Exclusion Criteria:

* Prior therapy with any JAK2 medications
* Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD
* Eye disease of the cornea

Primary outcomes:
measure: Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis)
timeFrame: Information will be collected from the time the informed consent is signed, throughout the study
Secondary outcomes:
measure: Evaluation of the pharmacokinetics of AZD1480
timeFrame: During all cycles
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca
name: Gregory Curt, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04224597: Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris
Official title: Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enthesitis
Acne Vulgaris
Ultrasonography
Keywords: enthesitis
acne vulgaris
Guess
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acne vulgaris and healthy controls aged between 18-25

Brief summary: Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies of inflammatory acne lesions. Therefore, acne is thought to be a Th17-related disease (1).

This study was aimed to evaluate the presence of enthesitis in patients with acne vulgaris.

Detailed description: Patients with acne vulgaris and healthy controls aged between 18-25 who admitted to Hitit University Erol Olcok Education and Research Hostpital Dermatology policlinic will be icluded. Patients with rheumatic, neurological diseases, history of trauma and previous fractures will be excluded from the study. After all the participants were evaluated by the dermatologist and demographic data will be recorded, the participants will be examined by the physical medicine and rehabilitation specialist and the short form-36 (sf-36), hospital anxiety and depression scale will be completed. Bilateral lower extremity tendon thicknesses and the presence of erosion, bursitis, etc. will be evaluated according to the criteria of Guess (Glasgow Ultrasound Enthesitis Scoring System) and Guess score will be determined for all participants. A total of 48 participants, 24 patients with acne vulgaris and 24 healthy controls, will be included in the study (2).

Eligibility criteria: Inclusion Criteira:

* Patients with acne vulgaris and healthy controls aged between 18-25

Exclusion Criteria:

* Participants with rheumatic and neurologic disease, history of trauma ,

Primary outcomes:
measure: patellar tendon thicknesses of patients with acne vulgaris and healthy controls
timeFrame: 3 months
measure: Ashilles tendon thicknesses of patients with acne vulgaris and healthy controls
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Dilek Eker Büyükşireci
state: Central Anatolia
Study officials:
References:
Clinical trial NCT04028297: Focus Cardiac Ultrasound in Patients With Shock
Official title: Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Keywords: Shock
emergency
undifferentiated
ultrasound
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with undifferentiated shock in the Emergency Department

Brief summary: The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee

Detailed description: Focus cardiac ultrasound (FoCUS) has already demonstrated its ability to reduce diagnosis uncertainty in patients with undifferentiated shock. However, adequacy of initial treatment has not been investigated.

In patients with undifferentiated shock, after clinical evaluation, the physician states its hypothesis and initial treatment intention in closed list. He realizes a FoCUS, states another time the hypothesis and begins treatment according to FoCUS results. An adjudication committee with all the patient's file will state the reference hypothesis and treatment

Eligibility criteria: Inclusion Criteria:

* Undifferentiated shock defined by systolic arterial pressure \< 90 mm Hg

Exclusion Criteria:

* hemorrhagic shock
* cardiac arrest
* anaphylactic shock
* documented end-of-life

Primary outcomes:
measure: concordance of initial treatment after FoCUS with Kappa coefficient
timeFrame: Hospitalization duration, up to one month
Secondary outcomes:
measure: duration of FoCUS
timeFrame: Hospitalization duration, up to one month
measure: difficulty of FoCUS
timeFrame: Hospitalization duration, up to one month
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT00195377: Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
Official title: Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Arthritis, Rheumatoid
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units

Brief summary: The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain


Eligibility criteria: Inclusion Criteria:

* RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
* Children from 4 to 17 years old with JIA polyarticular

Exclusion Criteria:

* Clinically significant abnormal screening lab values
* Patients who are planning to undergo elective surgery during the study period.
* Other current autoimmune connective tissue diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02062177: Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy
Official title: Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Endoscopy
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.


Eligibility criteria: Inclusion Criteria:

* age \< 18 years
* American Society of Anesthesiologists risk I-II
* patients undergoing to Gastroscopy or Colonoscopy

Exclusion Criteria:

* significant systemic disease
* allergic reactions to any of study drugs
* chronic use of opioids or psychiatric disorders
* pregnancy
* Mallampati score \> 2
* age \< 18 years

Primary outcomes:
measure: Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
timeFrame: at the end of the exam
measure: Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
timeFrame: before discharge
measure: Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
timeFrame: at 24-72 hours after procedure
Secondary outcomes:
measure: Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
timeFrame: one day
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: one day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: Vita-Salute San Raffalele University- San Raffaele Hospital
name: Pier Alberto Testoni, Professor
role: STUDY_DIRECTOR
References:
citation: Fanti L, Gemma M, Agostoni M, Rossi G, Ruggeri L, Azzolini ML, Dabizzi E, Beretta L, Testoni PA. Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial. Dig Liver Dis. 2015 Jul;47(7):566-71. doi: 10.1016/j.dld.2015.03.003. Epub 2015 Mar 14.
Clinical trial NCT05976477: Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients
Official title: Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: randomized controlled trial
older patients
polypharmacy
diet
salt intake
educational intervention
blood pressure
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 266
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with blinded endpoint with 1:1 (intervention to control arm) allocation ratio.

The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.


Eligibility criteria: Inclusion Criteria:

1. Community-dwelling patients aged ≥60 years;
2. Prescribed ≥3 drugs;
3. A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable antihypertensive therapy (at least 1 drug (ATC code: C02\*, C03\*, C07\*, C08\*, C09\*)); B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any antihypertensive drug;
4. Capable of feeding independently;
5. Own a smartphone;
6. Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month);
7. Giving signed informed consent.

Exclusion Criteria:

1. Living in a nursing home or having applied for nursing home admission;
2. Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment;
3. Undergoing renal replacement therapy with dialysis or having renal impairment with estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2 (assessed by CKD-EPI formula) \[30\] within previous six months or at the screening assessment;
4. Following a low-sodium dietary regimen;
5. Being unable or refusing to sign informed consent.

Primary outcomes:
measure: Change in systolic BP
timeFrame: 6 months
Secondary outcomes:
measure: Change in 24-hour urinary sodium excretion
timeFrame: 6 and 12 months
measure: Change in adherence to the mediterranean diet
timeFrame: 6 and 12 months
measure: Incidence of cardio- and cerebro-vascular events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Carlotta Franchi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577077: Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Participants of both sexes aged 18 and over
* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
* Participants with a diagnosis of perennial allergic rhinitis, as determined by a history of symptoms related to non-seasonal allergen exposure for at least 9 months in the 12 months prior to the screening visit.

Exclusion Criteria:

* Participants who have had nasal surgery in the six (6) months prior to the screening visit, or who have obvious external structural abnormalities that interfere with nasal airflow and are considered clinically relevant by the investigator;
* Participants with non-allergic rhinitis (e.g. vasomotor, infectious, medication or drug-induced rhinitis) or seasonal allergic rhinitis;
* Participants with a current diagnosis or history of chronic rhinosinusitis, chronic purulent postnasal drip in the two (2) years prior to the screening visit;
* Participants diagnosed with asthma requiring regular use of systemic or inhaled corticosteroids; uncontrolled asthma (ACT: 5-15); partially controlled asthma (ACT: 16-19);
* Participants with a history of immunotherapy treatment in the 2 years prior to the screening visit;
* Participants with an upper respiratory tract infection or rhinosinusitis requiring antibiotic treatment in the 14 days prior to the screening visit and the randomization visit;
* Participants with an upper respiratory tract viral infection in the 7 days prior to the screening and randomization visits;
* Participants with severe hypertension, severe coronary artery disease, arrhythmias, glaucoma, hyperthyroidism, prostatic hypertrophy.

Primary outcomes:
measure: Absolute reduction in the evening reflective total nasal symptom score (rTNSS)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: