louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05832398: Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer
Official title: Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Organoid
Drug Test
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Sun Yat-sen University
First posted: 2023-04-27
Enrollment: 186
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: TREATMENT

Brief summary: The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.

Detailed description: Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70
* Histological confirmed colorectal cancer
* Stage IV
* American Society of Anesthesiologists (ASA) score I\~III
* No contraindication for chemotherapy
* No evidence of other malignant tumor

Exclusion Criteria:

* Refusing chemotherapy
* Pregnant or breast-feeding women
* Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy

Primary outcomes:
measure: 1. Progression-free survival
timeFrame: up to 1 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jun Yan, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06783998: Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome
Official title: Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obstructive Sleep Apnea (OSAS)
Keywords: Obstruktive sleep apnea
sarcopenia
respiratory muscle
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with normal-mild-medium-severe Obstructive Sleep Apnea Syndrome

Brief summary: OSAS is a disease characterized by repeated interruptions and restarts of breathing during sleep. Respiratory muscle sarcopenia is a condition in which the muscle strength of the diaphragm and other respiratory auxiliary muscles decreases, resulting in a decrease in breathing effort. Decreased respiratory effort is an important indicator of OSAS. Age, presence of chronic disease, and obesity increase the presence and severity of respiratory sarcopenia. If OSAS is left untreated, it leads to cardiovascular diseases, dementia, Alzheimer's and even death in early adulthood. In recent years, studies have shown that continuous positive airway pressure (CPAP), as well as healthy behavior development, preventive health and exercise measures, are important in the management of these diseases. There is no research in the literature on the evaluation of respiratory muscle sarcopenia in OSAS patients.

This study aims to evaluate respiratory muscle sarcopenia in OSAS based on a concrete value reflecting respiratory muscle strength and/or volume.

Detailed description: In the study, respiratory muscle sarcopenia will be evaluated in OSAS patients. It will be evaluated whether the expiratory pressure value, peek flow meter value and 6-minute walking distance are predictors of respiratory sarcopenia for OSAS.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with normal-mild-medium-severe OSAS
* 18 years and above
* Turkish speaking patients will be included.

Exclusion Criteria:

* Pregnancy,

  * Latent autoimmune diabetes,
  * Chronic renal failure,
  * Active or serious infections,
  * Liver failure,
  * Recent major cardiovascular events,
  * Unstable angina, heart failure (NYHA III-IV),
  * Patients with neurological or musculoskeletal disorders that create limitations in walking and performing tests

Primary outcomes:
measure: Anthropometric measurement
timeFrame: 1 year
measure: BOdy mass measurement
timeFrame: 1 year
measure: Hand Grip strength
timeFrame: 1 year
measure: Walking speed
timeFrame: 1 year
measure: Respiratory muscle strength:
timeFrame: 1 year
measure: Expiratory flow rate
timeFrame: 1 year
measure: Respiratory function test
timeFrame: 1 year
Secondary outcomes:
measure: Functional capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
state: Mersi̇n
Study officials:
References:
Clinical trial NCT05248698: Dry Eye Response to Interval Exercise and Mediterranean Diet
Official title: Dry Eye Response to Interval Exercise (High Intensity Aerobic Activity) and Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Diet Habit
Physical Inactivity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended

Detailed description: older patient who will complain from dry eye will be collected. it is planned to recruit 60 elderly (with obesity and hypertension) to be distributed into group 1 (this group will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet) and group 2 (this group will receive only 3-time interval exercise per the week, applied for 30 min with high intensity). Every group will contain 30 elderly

Eligibility criteria: Inclusion Criteria:

* elderly patients with dry eye complaints
* the patients will be obese and hypertensives

Exclusion Criteria:

* heart or respiration problems
* other diagnosed eye or systemic diseases

Primary outcomes:
measure: Schirmer's test
timeFrame: 6 months
Secondary outcomes:
measure: scoring system for dry eye
timeFrame: 6 months
measure: Ocular surface disability index
timeFrame: 6 months
measure: tear film break up time testing
timeFrame: 6 months
measure: Oxford grading system
timeFrame: 6 months
measure: blood systole
timeFrame: 6 months
measure: blood diastole
timeFrame: 6 months
measure: weight
timeFrame: 6 months
measure: body mass index
timeFrame: 6 months
measure: waist circumference
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06730945: Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After CABG
Official title: A Multicenter, Randomized, Outcomes Assessor Blind, Parallel Controlled Trial to Evaluate the Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Bypass Graft Surgery (CABG)
Radial Artery Grafts
Graft Failure
Keywords: CABG
Radial artery grafts
Isosorbide Mononitrate
Amlodipine
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 500
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: The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.

The main question it aims to answer is:

Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .

Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.

Participants will

1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
3. Protocol-driven CCTA at Week 24 after CABG.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years old，
* Any sex，
* Signed informed consent，
* Within 3 days after primary isolated CABG using RA graft

Exclusion Criteria:

1. Allergy to isosorbide mononitrate or amlodipine.
2. Hypotension (systolic BP \<90 mmHg or diastolic BP \<60 mmHg)
3. Acute myocardial infarction or cardiogenic shock
4. Contraindications for CCTA examination (eg., iodine allergy)

Primary outcomes:
measure: The rate of RA graft failure at Week 24
timeFrame: at Week 24
Secondary outcomes:
measure: The time to first Major Adverse Cardiovascular Event (MACE)
timeFrame: within 24 weeks
measure: The proportion of participants with at least once symptomatic hypotension
timeFrame: within 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Qiang Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Cornell Medicine NewYork Presbyterian Hospital, NY, US
name: Mario FL Gaudino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Yunpeng Zhu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03728998: Non-invasive Measurement of CO in Patients With Uncomplicated Sepsis
Official title: Can Non-invasive Measurement of Cardiac Index, Stroke Volume and Systemic Vascular Resistance Contribute to Better Tailoring of Treatment in Patients Presenting With Sepsis to the ED?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Passive leg raise
Fluid responsiveness
Cardiac output, non-invasive
Emergency Department
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Little is known about the optimal fluid therapy of patients with uncomplicated sepsis. Most recommendations are extrapolated from studies performed in patients with septic shock. Therefore, it is unknown how effective our current fluid therapy is. Furthermore, current therapy is not tailored to individual needs. The aim of the current study is to investigate the added value of non-invasive measurements of (dynamic) circulatory parameters in the treatment of a convenience sample of sepsis patients presenting to the ED.


Eligibility criteria: Inclusion Criteria:

At presentation in the ED:

* there has to be evidence of an infection: -temp \<36 or \>38 without an obvious cause for hypo-or hyperthermia
* There has to be evidence of organ dysfunction by the presence of at least one of the following criteria: altered mental state, hypoxia (spo2\<94% or 5% lower than baseline), lactate \>2 mmol/l in ABGA or VBGA directly drawn after presentation, hypotension (MAP\<65 mmHg or SBP\<100mmHg), or a respiratory rate\>22/min.

Exclusion Criteria:

* Age\<16
* Patients with septic shock (i.e. who remained hypotensive after fluid bolus administration, needing vasopressor therapy to obtain a MAP\>65 in the presence of a lactate \>2. (i.e. septic shock) These will be excluded afterwards, but will be shown in an inclusion flowchart.
* Subjects for whom it is impossible to obtain a reliable signal for Clearsight measurements.
* Increased abdominal pressures
* Need for immediate ventilatory support or surgery
* Presence of an acute cerebral event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleed, trauma
* Known metastatic cancer
* Pregnancy

Primary outcomes:
measure: The percentage of subjects in whom a passive leg raise test resulted in a 15% or more improvement in cardiac index measured by the Clearsight non-invasive hemodynamic monitoring system.
timeFrame: 1 hour
Secondary outcomes:
measure: The ability of non-invasively measured baseline CO, CI, SVR and SV to predict fluid-responsiveness correctly (measurements by the Clearsight non-invasive hemodynamic monitoring system).
timeFrame: 1 hour
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
Study officials:
affiliation: Medisch Centrum Leeuwarden
name: Ewoud ter Avest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825145: Preeclampsia and Contact Activation
Official title: Preeclampsia and Contact Activation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
CAS
Misfolding Disease, Protein
Keywords: Contact activation system, PAI-2
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: OPEN
name: Lida og Oskar Nielsens Fond
name: Esbjerg Fonden
name: Gangsted Fonden
First posted: 2021-04-01
Enrollment: 234
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preeclamptic women anytime of pregnancy compared to healthy pregnant women (control) at the same gestational age, with matching BMI and age.

Brief summary: Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome.

PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis.

Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE.

The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.


Eligibility criteria: Inclusion Criteria:

* Pregnant women developing preeclampsia

Exclusion Criteria:

* Healthy pregnant women

Primary outcomes:
measure: The Contact Activation System (CAS)
timeFrame: 3 years
measure: Misfolded Plasminogen activator inhibitor 2 (PAI-2)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: The Unit for Thrombosis Research, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Jørgen B Gram, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03157245: Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery
Official title: Interest of Doppler Ultrasound for the Assessment of Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Central Venous Catheter Thrombosis
PARENTERAL NUTRITION
POST OPERATIVE
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient \> 18 years old, admitted in surgical critical care, immediatly after elective carcinologic surgery with a central venous catheter for parenteral nutrition

Brief summary: The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Detailed description: The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.

The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Eligibility criteria: Inclusion Criteria:

* Hospitalization in surgical intensive care in the immediate post-operative period
* surgery for cancer
* central venous catheter placement for parenteral nutrition
* written consent dated and signed before doppler examination

Exclusion Criteria:

* patient \< 18 years old
* pregnancy
* surgery with no indication for parenteral nutrition on central venous access

Primary outcomes:
measure: Presence or no of a catheter related thrombosis
timeFrame: 1 day (day of the catheter removal)
Secondary outcomes:
measure: clinical factors associated with the presence of catheter related thrombosis
timeFrame: post operative period, during the intensive care unit stay
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: NOVY
Study officials:
References:
Clinical trial NCT01162798: Preterm Infant Growth
Official title: Growth of Preterm Infants Consuming Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Development
Infant
Keywords: infant formula
premature infants
Growth and Development
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 150
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.


Eligibility criteria: Inclusion Criteria:

* Born AGA
* Exclusively formula-fed
* 28-34 weeks GA at birth
* Intact GI tract, tolerating full oral feeds
* Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion Criteria:

* Severe respiratory disease defined as needing mechanical ventilation at discharge
* Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
* Major congenital malformation, history of GI surgery, severe postnatal complications
* Daily or routine diuretic use at time of discharge
* Receiving more than 10% of daily kcals from food additives such as thickeners
* Currently participating or having participated in another conflicting clinical trial.

Primary outcomes:
measure: Growth
timeFrame: 4 months
Secondary outcomes:
measure: growth, tolerance, morbidity
timeFrame: 6 months
measure: Total body bone mineral content and density and body composition, protein status, and metabolic markers
timeFrame: corrected term and 4 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital & Research Center
state: California
city: Park Ridge
country: United States
facility: Advocate Lutheran Children's Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Omaha
country: United States
facility: Center for Human Nutrition
state: Nebraska
city: Morristown
country: United States
facility: Midatlantic Neonatology Associates, Inc
state: New Jersey
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Salt Lake City,
country: United States
facility: University of Utah, Dept of Pediatrics
state: Utah
city: Richmond
country: United States
facility: VCU Children's Medical Center
state: Virginia
Study officials:
affiliation: University of Iowa
name: Ekhard Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References: