louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03754231: Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Official title: Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Sign
Heart Rate
Respiratory Rate
Keywords: Vital sign monitoring
Heart rate
Respiratory rate
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Renew Group
First posted: 2018-11-27
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Detailed description: RENEW's Surveillance Monitoring system is made up of two main components:

a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. In the paediatric population, assessment of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared against a commonly used vital signs monitor. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Eligibility criteria: Inclusion Criteria:

* Male or female paediatric patients, aged between 3 and 17 years
* Patients attending outpatient care at KK Women's and Children's Hospital, Singapore

Exclusion Criteria:

* Patients with active, implantable devices (such as a pacemaker or ICD)
* Patients with any skin condition or injury affecting the electrode placement site
* Patients that are pregnant
* Those patients who, in the opinion of the clinic staff, are not suitable to participate.

Primary outcomes:
measure: Heart rate comparison
timeFrame: 15 minutes
Secondary outcomes:
measure: Respiratory rate comparison
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Bao Bei Kelly Low
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031831: Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease
Official title: Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Pediatric
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 999
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients (age \<18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020

Brief summary: This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.


Eligibility criteria: Inclusion Criteria:

* all pediatric patients (age \<18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.

Exclusion Criteria:

* with much missing clinical data

Primary outcomes:
measure: surgical mortality
timeFrame: 1 year
measure: intermediate survival
timeFrame: 5 years
Secondary outcomes:
measure: post-operative ICU stay
timeFrame: 1 year
measure: post-operative intubated days
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei City 100
country: Taiwan
facility: Jenghung Wu
state: Taiwan R.
Study officials:
References:
Clinical trial NCT03459131: Clinical Evaluation of Two Monthly Contact Lenses
Official title: Clinical Evaluation of Two Monthly Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an approved informed consent form (ICF);
* Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Refractive, ocular, or intraocular surgery, as specified in the protocol;
* Current or history of eye injury or disorders, as specified in the protocol;
* Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
* Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications that would require instillation during contact lens wear;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Subjective Rating of Overall Vision
timeFrame: Day 7, each product
Secondary outcomes:
measure: Over-refraction
timeFrame: Day 1 (Dispense), each product
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT05526131: BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression
Official title: Brain Derived Neurotropic Factor Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With Type Two Diabetes Mellitus and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Diabetes Mellitus
Keywords: Brain Derived Neurotrophic Factor
Diabetes Mellitus
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aimed to evaluate the relation between the levels of (Brain Derived Neurotropic Factor) BDNF and val66met polymorphism of BDNF gene, and the presence of depression in type 2 diabetes. In addition to studying the relationship between BDNF level and val66met polymorphism of its gene and assessing relation between BDNF level and obesity.

Detailed description: The study included 88 type 2 diabetic patients, which are further divided into two groups; depressed and non-depressed. Depression was assessed by Hamilton Depression Rating Scale (HAM-D) and structured clinical interview for DSM-IV Axis disorder (SCID-I) for diagnosing depression and exclusion of other psychiatric disorders. Genotyping was performed by using Real Time-PCR (TaqMan probes).

Eligibility criteria: Adult patients who have type two diabetes with or without depression.

Primary outcomes:
measure: BDNF level in blood
timeFrame: 1 day (At the time of recruitment)
measure: val66met polymorphism of BDNF gene
timeFrame: 1 day (At the time of recruitment)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
affiliation: Kasr Alaini University Hsopitals
name: Tarek Abdelaziz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767931: Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
Official title: Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: invasive breast cancer

Brief summary: This is a prospective, single-center, non-randomized, non-controlled study

Detailed description: Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.

In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.

Eligibility criteria: Inclusion Criteria:

1. Women between 18 and 70 years old；
2. Primary lesion \>2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination；
3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments；
4. Subjects signed informed consent；

Exclusion Criteria:

1. A history of prior or concomitant malignancies;
2. Advanced stage breast cancer (stage IV)；
3. Suspected or confirmed lesion was surgically removed；
4. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；

Primary outcomes:
measure: antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Breast center at Peking University Cancer Hospital
name: Zhaoqing Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456131: Prevention of Obesity at Universities: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-04-04
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a nutrition and behavior-based intervention conducted at Drexel University and the University of Pennsylvania with college women during their freshman year. It involves attending groups where life skills and eating behaviors are taught to help them control their weight and physical health.


Eligibility criteria: Inclusion Criteria:

* A variety of risk factors for later life weight gain

Exclusion Criteria:

* Current or past history of eating disorder

Primary outcomes:
measure: Weight
timeFrame: baseline, 6 weeks, 6 months, 12 months, 24 months
measure: blood work
timeFrame: baseline, 6 months, 24 months
measure: questionnaire data
timeFrame: baseline, 6 weeks, 6 months, 12 months, 24 months
measure: Body Composition
timeFrame: baseline, 6 months, 24 months
Secondary outcomes:
measure: dietary recalls
timeFrame: baseline, 6 weeks, 6 months, 12 months, 24 months
measure: Pedometer readings
timeFrame: baseline, 6 weeks, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Phildadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Michael R Low, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowe MR, Feig EH, Winter SR, Stice E. Short-term variability in body weight predicts long-term weight gain. Am J Clin Nutr. 2015 Nov;102(5):995-9. doi: 10.3945/ajcn.115.115402. Epub 2015 Sep 9.
citation: Berner LA, Arigo D, Mayer LE, Sarwer DB, Lowe MR. Examination of central body fat deposition as a risk factor for loss-of-control eating. Am J Clin Nutr. 2015 Oct;102(4):736-44. doi: 10.3945/ajcn.115.107128. Epub 2015 Sep 9.
Clinical trial NCT00006331: Prospective Controlled Study of Posttransplant Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Kidney Failure
Keywords: Kidney transplantation
Immunology
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-10-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Research participants will be asked to undergo complete medical history, physical examination and blood tests. The purpose of these tests is to determine whether persons are predisposed to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis if a patient develops diabetes mellitus. Medical information collected as part of the standard transplant evaluation and posttransplant medical care may be incorporated into this study. It is important to realize that research subjects will not be given an experimental drug as part of this study.

After kidney transplantation, research subjects will be followed in the posttransplant clinic visits. The study will last up to 6 months. During this time the subjects may be asked to participate in clinical assessment visits (medical history and physical examination), and also during the third or fourth month after transplant will be asked to do a repeat glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* Fasting Plasma Glucose (FPG) \<126mg/dl.
* No history of diabetes mellitus or treatment with oral antidiabetic agent or insulin.
* ESRD or chronic renal failure with CrCl \<= 20cc/min per 1.73m2.
* Waiting list registration for cadaveric or set date for living donor renal transplantation.
* Willingness and ability to understand and give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: 3914 Taubman Center
state: Michigan
Study officials:
References:
Clinical trial NCT03135431: Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery
Official title: Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.

Detailed description: A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* 21 years of age or older
* Desire permanent sterilization
* Scheduled for a Cesarean delivery

Exclusion Criteria:

* Body Mass Index \> 50
* Emergent, 'alpha' Cesarean delivery
* Single ovary/fallopian tube complex

Primary outcomes:
measure: Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
timeFrame: At least 24 but not greater than 48 hours after surgery
Secondary outcomes:
measure: Operative Time
timeFrame: Day of surgery
measure: Estimated Blood Loss
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vanessa E Torbenson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05059431: The Effect of Human Prostate Tissue on Platelet Activation
Official title: The Effect of Human Prostate Tissue on Platelet CD40 Ligand, Toll-like Receptor 4, P-selectin and Platelet-Leukocyte Aggregation: an In Vitro Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Hyperplasia
Coagulation; Intravascular
Thrombotic Disorder
Keywords: TURP
coagulopathy
DIC
thrombotic disorder
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 8
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40-80 year old male scheduled for transurethral resection of the prostate surgery.

Brief summary: Transurethral resection of the prostate (TURP) is a common and standard urological surgical procedure for managing benign prostatic hyperplasia (BPH). Although surgical technology improved in recent decades, severe complications such as TURP syndrome, hematuria, and postoperative hemorrhage were still considerable. Coagulopathy is one of rare but devastating complication which may contribute to bleeding during and after TURP. Although the exact pathophysiological condition of coagulopathy is not clear, there are several possible mechanisms of TURP associated coagulopathy including: urokinase- (u-PA) and tissue-type plasminogen activator (t-PA)-related fibrinolysis; absorption of irrigating fluid associated dilutional coagulopathy; release of prostatic particles rich in tissue thromboplastins into the circulation causing secondary ﬁbrinolysis and disseminated intravascular coagulopathy (DIC); sepsis with DIC associated with bacteria entering the circulation due to prostatic venous sinuses opening and the using of high pressure irrigation. On the other hand, platelet are essential to hemostasis and thrombosis and its activation also contributes to leukocyte recruitment and DIC. Furthermore, previous studies demonstrated that activated platelets could express TLR4, CD40L, P-selectin and induce platelet-leukocyte aggregation (PLA), which were considered important for systemic inflammatory responses and DIC development. Currently, no study investigating the association of prostate particle and platelet activation. Here, we tested the hypothesis that prostate tissue may induce inflammatory responses through platelet activation by measuring the expression of TLR4, CD40L, P-selectin and PLA on platelets.


Eligibility criteria: Inclusion Criteria:

* scheduled for TURP surgery

Exclusion Criteria:

* morbid obesity, bedridden, thromboembolic disease, sepsis, nephrotic syndrome, trauma, malignant tumor, disease associated with increasing blood viscosity.

Primary outcomes:
measure: TLR4, CD40L and P-selectin expression
timeFrame: 2 hour, during surgical period
measure: Platelet leukocyte aggregation
timeFrame: 2 hour, during surgical period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: