louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05917418: Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
Official title: Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

Detailed description: Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich \& it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).

Investigators propose to survey the prevalence of malnutrition \& nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.

Investigators also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.

For international cooperation, the partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011.

Eligibility criteria: Inclusion Criteria:

* patients be in hospital overnight
* diagnoses according to the protocol of cohort study for cost effectiveness

Exclusion Criteria:

* patients admitting from emergency department
* patients who undergone operation before second morning of hospitalization
* patients who dose not give Informed Consents

Primary outcomes:
measure: The incidence of Infectious complication
timeFrame: during the hospital stay
Secondary outcomes:
measure: Total cost amount
timeFrame: during the hospital stay
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06788418: Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
Official title: Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: myopia
Small Incision Lenticule Extraction
Implantable Collamer Lens
Wavelight Plus Alcon system
vision
Lead sponsor: Beijing Visionly Plus Eye Hospital
Sponsor class: OTHER
Collaborators: name: High Myopia Control Alliance (HIMALAYA)
name: Beijing New Vision Eye Hospital
name: Shanghai Parkway Hospital
First posted: 2025-01-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-40 years
* Spherical equivalent of -1.00 to -10.00 D
* Stable refraction for at least 12 months
* Informed consent provided

Exclusion Criteria:

* Other ocular pathologies
* Previous refractive surgery
* Pregnancy or nursing
* Autoimmune or connective tissue disorders

Primary outcomes:
measure: Vision at 12 months post-surgery
timeFrame: From the day of surgery through to the 12-month post-operative follow-up
Secondary outcomes:
measure: Change in spherical equivalent at 12 months post-surgery
timeFrame: From the day of surgery through to the 12-month post-operative follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing New Vision Eye Hospital
city: Beijing
country: China
facility: Beijing Visionly Plus Eye Hospital
Study officials:
References:
citation: Meng ZY, Yang L, Zhou P. Femtosecond laser versus manual clear corneal incision in implantable collamer lens surgery. Sci Rep. 2025 Jan 7;15(1):1086. doi: 10.1038/s41598-024-81477-w.
Clinical trial NCT04205318: FTO Gene Variants and Diet in Obesity
Official title: Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diet Habit
Genetic Predisposition
Keywords: obesity
gene-diet interaction
FTO gene variant
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: University of Reading
name: The Scientific and Technological Research Council of Turkey
First posted: 2019-12-19
Enrollment: 400
Sex: ALL
Minimum age (years): 24
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 unrelated individuals, aged 24-50 years

Brief summary: Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.


Eligibility criteria: Inclusion Criteria:

1. attending routine outpatient visits,
2. aged 24 to 50 years,
3. having a BMI ≥ 18.50 kg/m2

Primary outcomes:
measure: Genetic analysis of two SNPs at FTO gene
timeFrame: up to 36 weeks
measure: Anthropometric measurements
timeFrame: up to 36 weeks
measure: Biochemical measurements
timeFrame: up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zehra Buyuktuncer
Study officials:
affiliation: Hacettepe University, Department of Nutrition and Dietetics, Ankara, TURKEY
name: Zehra Buyuktuncer
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food and Nutritional Sciences, University of Reading, UK
name: Vimales Karani Santhanakrishnan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684418: Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer
Official title: Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer: A Multicenter, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC (Non-small Cell Lung Cancer)
Artificial Intelligence (AI)
Lymphnode Metastasis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 6000
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: Early-stage NSCLC receiving curative treatment (surgery or SBRT).

Brief summary: This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer;
* Clinical stage I (AJCC, 8th edition, 2017);
* Age≥18 years old;
* KPS score≥70;
* Patients who have undergone primary NSCLC radical surgery or SBRT treatment;
* Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT treatment (Note: Tumor size ≥ 3 cm or centrally located tumor requires PET/CT and/or invasive mediastinal staging);
* Patients willing to cooperate with the follow-up after primary NSCLC radical surgery;
* informed consent of the patient.

Exclusion Criteria:

* Poor quality of computed tomography imaging;
* Baseline imaging shows pure ground-glass nodules (GGO);
* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
* Loss to follow-up.

Primary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan university Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT05513118: Menopause and Oral Health
Official title: Evaluation of the Relationship Between Menopause and Periodontal Health With Biochemical and Microbiological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Periodontal Diseases
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2022-08-24
Enrollment: 148
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population comprised of two main groups as postmenopausal women (PMW) and regularly menstruating women (RMW). The women in the PMW group were included if they were under 65 years of age and had a history of spontaneous amenorrhea for the last 12 months.

Brief summary: Menopause is characterized by major physiological and concomitant psychological changes. The study aimed to evaluate the association between oral health parameters, bone mineral density (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were further aimed. The participants were asked to complete the Women's Health Questionnaire to measure emotional and physical well-being.

A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass indices (BMI) were obtained from their medical records.


Eligibility criteria: Inclusion Criteria:

* Being 35-65 years of age
* Having history of spontaneous amenorrhea for the last 12 months for PMW.
* Lack of irregularity in menstrual cycles during the past 12 months for RMPW.
* Possessing at least 10 natural teeth without any prosthetic restoration

Exclusion Criteria:

* History of antibiotics use in last 3 months
* Ongoing cancer therapy
* Presence of oral ulcers or acute infectious disease
* Presence of diabetes mellitus

Primary outcomes:
measure: Periodontitis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01684618: Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
Official title: Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygenation
Keywords: Preterm
Neonate
Newborn
Cerebral oxygenation
CPAP
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: The Ludvig & Sara Elsass Foundation
First posted: 2012-09-13
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: * Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
* The purpose of the study is to investigate our hypothesis that a particular CPAP flow pressure optimizes the regional cerebral oxygenation.

Detailed description: Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. Preterm infants is often treated with CPAP (Continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known.

The investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.

There will be no follow-up.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: - Newborns with a gestational age of 32-40 weeks - Clinically stable - +/- CPAP with a oxygen limit below 30% - Parental consent

Exclusion Criteria:

* Severe birth asphyxia - Prohibition of oxygen exposure

Primary outcomes:
measure: Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure
timeFrame: Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Paediatrics, Copenhagen University Hospital; Hvidovre
Study officials:
References:
Clinical trial NCT02586818: Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting
Official title: Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Blood Dyscrasia
Lead sponsor: Accriva Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2015-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population to be studied consists of subjects who require oral anticoagulant therapy with VKA in accordance with the approved label indications for VKA administration. Normal healthy individuals will also be enrolled to collect data to support the low end of the lnRhythm system detection range.

Brief summary: This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.


Eligibility criteria: Inclusion Criteria - All

* The subjects must be \> 18 years of age.
* The subjects must be willing and competent to sign an informed consent.
* The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.

Exclusion Criteria - All

* The subject is unable to donate fingerstick and venous blood samples.
* The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
* The subject is enrolled in any other study that involves an investigational drug and/or device.

Additional Inclusion Criteria - Therapeutic Group

* The subject must require oral VKA anticoagulant therapy.
* The patient must have been anticoagulated for at least three months prior to enrollment.

Additional Exclusion Criteria - Normal Group

- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.

Primary outcomes:
measure: Comparison of INR measurements
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00437918: The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
Official title: Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-02-21
Enrollment: 85
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.


Eligibility criteria: Inclusion Criteria:

* Korean
* Type 2 diabetes mellitus
* No prior history of diabetic ketoacidosis
* HbA1c between 7.5-10.0%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Gestational diabetes mellitus
* Secondary diabetes mellitus
* Severe hyperglycemia with symptoms
* Severe chronic diabetic complications (PDR,s-Cr\>1.3mg/dL)

Primary outcomes:
measure: 7 point SMBG (self monitoring of blood glucose)
Secondary outcomes:
measure: HOMA-beta for predicting the effectiveness of each agents
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
city: Busan
country: Korea, Republic of
facility: Endocrinology and Metabolism, Maryknoll General Hospital
Study officials:
affiliation: Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
name: Jeonghyun Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MK, Suk JH, Kwon MJ, Chung HS, Yoon CS, Jun HJ, Ko JH, Kim TK, Lee SH, Oh MK, Rhee BD, Park JH. Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jun;92(3):322-8. doi: 10.1016/j.diabres.2011.01.022. Epub 2011 Mar 3.
Clinical trial NCT02243618: The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Adenoma
Early Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 153
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.


Eligibility criteria: Inclusion Criteria:

1. Age, between 19 and 79
2. Patients with gastric adenoma or early gastric cancer
3. Patients with ECOG-PS 0 or 1
4. Patients with adequate renal function
5. Patients with adequate hepatic function
6. Patients with adequate bone marrow function

Exclusion Criteria:

1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD.
2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.
3. Patients who has undergone gastrostomy
4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide.
5. Pregnant or breast feeding.

Primary outcomes:
measure: Ulcering healing rate
timeFrame: 4 weeks after the ESD
Secondary outcomes:
measure: Scarring change rate
timeFrame: 4 weeks after the ESD
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance hospital
Study officials:
References: