louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04899128: Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer
Official title: Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer: A Real World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2-positive metastatic breast cancer patients who failed by lapatinib received pyrotinib

Brief summary: This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

Detailed description: HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

Eligibility criteria: Inclusion Criteria:

* Female and 18-70 years old
* Metastatic or locally recurrent HER2-positive breast cancer
* Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis
* Complete and accurate medical data

Exclusion Criteria:

- Incomplete medical data

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References:
citation: Hua Y, Li W, Jin N, Cai D, Sun J, Sun C, Yang F, Wu X, Huang X, Wang B, Yin Y. Treatment with pyrotinib-based therapy in lapatinib-resistant HER2-positive metastatic breast cancer: a multicenter real-world study. Ther Adv Med Oncol. 2022 Mar 24;14:17588359221085232. doi: 10.1177/17588359221085232. eCollection 2022.
Clinical trial NCT01493128: Ultrastructure of Atrial Myocytes in Patients in Sinus Rhythm and With Atrial Fibrillation
Official title: Ultrastructure of Sarcolemma, Immunofluorescence of Calcium Handling Proteins and Mitochondrial Function in Atrial Myocytes of Patients in Sinus Rhythm and With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
atrial cells
myocardial tissue
t-tubules
immunofluorescence
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: selected for open heart surgery in St Olavs Hospital, Trondheim University Hospital, Norway

Brief summary: The aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Furthermore, since current information is lacking on the key Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. Mitochondrial function will also studied.

1. The investigators hypothesize that both structure of sarcolemma and localization of key Ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm.
2. The investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.


Eligibility criteria: Inclusion Criteria:

* sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation
* selected for open heart surgery
* informed consent

Exclusion Criteria:

* not given informed consent

Primary outcomes:
measure: structure of sarcolemma
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, PhD
role: STUDY_DIRECTOR
References:
citation: Slagsvold KH, Johnsen AB, Rognmo O, Hoydal MA, Wisloff U, Wahba A. Mitochondrial respiration and microRNA expression in right and left atrium of patients with atrial fibrillation. Physiol Genomics. 2014 Jul 15;46(14):505-11. doi: 10.1152/physiolgenomics.00042.2014. Epub 2014 May 13.
Clinical trial NCT03060928: Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
Official title: Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Rotator Cuff Tear
Artelon®
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.

The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.


Eligibility criteria: Inclusion Criteria:

* a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
* signed informed consensus

Exclusion Criteria:

* previous fractures
* diabetes
* subscapularis tears
* tears \< 1cm or \> 3 cm
* reduced passive range of motion
* infections
* known mental or neurological disorders unwilling or unable to follow the post-surgery instructions
* conditions that contraindicate arthroscopic rotator cuff surgery
* patients without complete osteogenesis
* pregnant or breastfeeding women

Primary outcomes:
measure: Retear rate
timeFrame: 12 months post-operatively
Secondary outcomes:
measure: Constant-Murley
timeFrame: 3, 6, 12 months post-operatively
measure: DASH
timeFrame: 1, 3, 6, 12 months post-operatively
measure: VAS
timeFrame: 1, 3, 6, 12 months post-operatively
measure: Passive ROM
timeFrame: 1, 3, 6, 12 months post-operatively
measure: Adverse events
timeFrame: 1, 3, 6, 12 months post-operatively
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Roberto Leo
Study officials:
References:
Clinical trial NCT04363528: Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Official title: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: Deep Vein Thrombosis
doppler echo
SARS-CoV-2
ICU
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU.

This is a monocentric interventional study (RIPH 2).


Eligibility criteria: Inclusion Criteria:

* Patient \> or =18 years
* Hospitalization in intensive care
* PCR COVID 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of taste, anosmia) associated with compatible radiological signs

Exclusion Criteria:

* Pregnancy in progress
* Patient \<18 years
* Patients deprived of freedoms or under guardianship
* Patient or family opponent of protocol participation
* patient on curative anticoagulant for more than 48H00
* impossible Venous Doppler Echo

Primary outcomes:
measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
timeFrame: Day 0
measure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
References:
Clinical trial NCT05988528: Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
Official title: Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.

Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Both male and female will be
* Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

* Breast feeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Other inflammatory bowel diseases (CD).
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
* Addiction to alcohol and / or drugs
* Known allergy to the Fenofibrate

Primary outcomes:
measure: The primary endpoint is the improvement in health-related quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT02323828: High Resistant Starch (RS) Cookies and Appetite Control
Official title: Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo.

Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).


Eligibility criteria: Inclusion Criteria:

* self-reported healthy
* not suffering disorders of lipid metabolism and eating disorders

Exclusion Criteria:

* pregnant or breast-feeding
* consuming an energy-restricted diet
* vegan or vegetarians

Primary outcomes:
measure: Consumption of RS on appetite regulation
timeFrame: One day
measure: Consumption of RS on appetite regulation
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02244528: PK Study of Sildenafil in Neonate
Official title: Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neonates and Preterm Infants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2014-09-19
Enrollment: 20
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.


Eligibility criteria: Inclusion Criteria:

* Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
* Infants who were diagnosed with PAH

Exclusion Criteria:

* Severe allergic reaction to sildenafil
* Inotropics for hypotension within 3 days prior to enrollment
* AST or ALT \> 3x ULN
* Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud

Primary outcomes:
measure: AUC(0-t)
timeFrame: t up to 5 weeks
measure: Cmax(0-t)
timeFrame: t up to 5 weeks
Secondary outcomes:
measure: Change from baseline in pulmonary arterial hypertension at 5 weeks
timeFrame: pre, 2 weeks, 5 weeks of drug administration
measure: respiratory severity score
timeFrame: pre, 2 weeks, 5 weeks after administration
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06824428: The Pain Perception Threshold in Attention Deficit Disorder With Hyperactivity
Official title: Can the Disease Subtype Affect the Pain Perception Threshold in Children Diagnosed With Attention Deficit Disorder With Hyperactivity?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain Threshold
Attention Deficit Disorder With Hyperactivity (ADHD)
Lead sponsor: Sultan 1. Murat State Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-13
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from among those who apply to Edirne Sultan 1. Murat State Hospital Child and Adolescent Mental Health and Diseases polyclinic.

Brief summary: The aim of this study was to evaluate whether the disease subtype affects the presence of chronic pain and pain perception threshold in pediatric patients followed up with the diagnosis of attention deficit and hyperactivity disorder, and to evaluate the factors that may be related to pain perception threshold in disease subtypes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with attention deficit and hyperactivity disorder according to DSM-5 diagnostic criteria
* Being between the ages of 6-17
* Being at a clinically normal mental level

Exclusion Criteria:

* Having verbal and visual communication problems
* Having a history of perinatal complications or physical head trauma
* Having comorbid psychiatric disorders other than oppositional defiant disorder and conduct disorder
* Known history of chronic physical and neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune diseases, liver and kidney failure)
* Presence of substance or alcohol use disorder
* Having a genetic disorder diagnosis

Primary outcomes:
measure: pressure pain threshold
timeFrame: Baseline
Secondary outcomes:
measure: Presence of chronic pain
timeFrame: Baseline
measure: Pain score
timeFrame: Baseline
measure: Duration of chronic pain
timeFrame: Baseline
measure: Sociodemographic data of patient
timeFrame: Baseline
measure: Sociodemographic data of patient's parents
timeFrame: Baseline
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Sultan 1. Murat State Hospital
Study officials:
affiliation: Sultan 1. Murat State Hospital
name: İbrahim Tiryaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02915328: Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Stenosis
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 100
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: Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.

The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.


Eligibility criteria: Inclusion Criteria:

significant, unilateral carotid artery stenosis with soft plaque defined as:

* symptomatic patients: \> 1.3 m/sec peak systolic velocity and \> 50% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography
* asymptomatic patients \> 2.5 m/sec peak systolic velocity and \> 70% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography

Exclusion Criteria:

* severe cerebral vasculopathy with cognitive impairment
* contraindication to double antiplatelet treatment
* controlateral carotid occlusion

Primary outcomes:
measure: number of microembolization signals (MES) detected with transcranial doppler
timeFrame: intraprocedural
Secondary outcomes:
measure: Clinical success
timeFrame: day 2 or day 3 and day 30 complication
measure: 6 month clinical follow up
timeFrame: 6 month
measure: Doppler ultrasound assesment
timeFrame: day 2 or day 3, 1 month and 6 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
state: MI
Study officials:
affiliation: Centro Cardiologico Monzino, IRCCS
name: Piero Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
Clinical trial NCT06053528: Pattern and Outcomes of Chest Diseases
Official title: Pattern and Outcome of Respiratory Diseases in Patients Admitted in the Chest Department at Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chest--Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective, descriptive and analytical study.

Brief summary: The objective of this study is to determine the pattern and outcome of respiratory diseases in adults patients admitted to the Department of Chest Diseases at Assiut University Hospital.

Detailed description: Respiratory diseases constitute an important global health burden. Pneumonia, tuberculosis, obstructive and restrictive lung diseases, pleural diseases, and malignancies are common respiratory conditions for hospital admission.Before the emergence of COVID-19, pneumonia, including community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP)/ventilation-associated pneumonia (VAP), was one of the most common infectious diseases, and could cause major health problems, associated with high morbidity and mortality in all age groups worldwide . The outbreak of COVID-19 has significantly changed the epidemiology of respiratory tract infection. More than 376 million people have been infected and 5 million have died in the whole world. This in addition to the long term post COVID pulmonary sequelae. Chronic obstructive pulmonary disease (COPD), lower respiratory tract infections, lung cancer and tuberculosis have been identified as top four respiratory diseases among ten leading causes of death worldwide. The forum of international respiratory societies (FIRS) estimated that 65 million people have moderate to severe COPD resulting in 3 million deaths per year, making it third leading cause of death worldwide .Currently, asthma affects an estimated 334 million people worldwide and is projected to increase to 400 million by the year 2025 .

In ;2015 10,4million people developed TB with 1.4 million global deaths were reported.

Neoplasms of the lungs are the leading cause of cancer incidence and mortality worldwide.

Eligibility criteria: Inclusion Criteria:

* All adults patients admitted to the Chest Department during the study period will be included.

Exclusion Criteria:

* Patients who will die, be discharged, or be transferred before completing data collection will be excluded from our study.

Primary outcomes:
measure: Determine number of patients who experience improvement on discharge
timeFrame: One year
measure: Number of patient who Transferred to another hospital forcontintreatment
timeFrame: One year
measure: Number of patient died while on admission
timeFrame: One year
measure: Number of patient who Discharged against medical advice
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: