louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03844139: Effect and Complication of Two Types of Nasogastric Tube Feeding for Elderly Dysphagia Patient After Stroke
Official title: Observation of Effect and Complication of Two Types of Nasogastric Tube Feeding Enteral Nutrition for Elderly Dysphagia Patients After Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deglutition Disorders
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every 50 patients in each group

Brief summary: Dysphagia is a common problem after stroke.Patients after stroke with swallow problem will have a nasogastric tube to be feeded. In this study , investigators have including and excluding criteria. Continous feeding group and intermittent feeding group had been widely used in enteral nutrition feeding in investigators' institution. Investigators will observe participants' nutrition condition and tube-feeding related complications. In continous group patients, participants usually are given prescribed enteral nutrient solution using nutrition pump in 24 hours; while in intermittent feeding group, participants will be given prescribed enteral nutrient solution in 4-5 times by special syringe. During the whole process, investigators will observe all participants' nutrition condition (body mass index, plasma albumin and calf girth) and tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation). With all those data, the investigators will assess which feeding type is better.


Eligibility criteria: Inclusion Criteria:

* Older than 65 years old
* Clinical diagnosis of stroke( ischemic and hemorrhage)
* With moderate and/or sever swallow problem(water swallow test IV-V degree)
* With nasogastric feeding tube more than 4 weeks
* Do rehabilitation in our hospital or designated hospitals

Exclusion Criteria:

* Without nasogastric feeding tube
* Patients with fever and other infection
* Chronic or acute anoxia
* Poor obedience
* Quit treatment or go back home to take rehabilitation
* Critically ill or died

Primary outcomes:
measure: weight
timeFrame: 4-6 weeks
measure: plasma albumin
timeFrame: 4-6 weeks
measure: tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation)
timeFrame: 4-6 weeks
Secondary outcomes:
measure: calf girth
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhangy Yuejiao
state: Zhejiang
Study officials:
References:
Clinical trial NCT01525225: Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Official title: Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage® (Metformin) IR Tablets
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Detailed description: The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of T2DM
* Male and female subjects ages 10-17
* Body weight ≥50 kg
* Glycosylated hemoglobin (HbA1c) 6.5 to 10%

Exclusion Criteria:

* Fasting plasma glucose (FPG) \> 240 mg/dL at screening
* Abnormal renal function
* Active liver disease and/or significant abnormal liver function

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
timeFrame: Day 1 up to Day 8, plus 30 days
Secondary outcomes:
measure: Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities
timeFrame: Day 1 to Day 8
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Osborne Research Center
state: Arkansas
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Kansas City
country: United States
facility: The Children'S Mercy Hospital And Clinics
state: Missouri
city: Toledo
country: United States
facility: Promedica Toledo Children'S Hospital
state: Ohio
city: Toledo
country: United States
facility: Promedica Toledo Childrens Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Childrens Hospital Of Pittsburgh Of Upmc
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02263625: Regional Differences In Indication for Ventral Hernia Repair
Official title: Regional Differences In Indication for Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: Indication
Differences
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014

Brief summary: The aim of the present study is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark.

Detailed description: 30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.

Eligibility criteria: Inclusion Criteria:

* Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014

Primary outcomes:
measure: Differences in indication for ventral hernia repair
timeFrame: 6 months
Secondary outcomes:
measure: Differences in choice of surgical technique between surgeons
timeFrame: 6 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Sygehus
Study officials:
affiliation: dept. of surgery, Køge University Hospital
name: Dunja Kokotovic, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01273025: Lime Powder Regimen in Healthy Volunteers
Official title: Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Kidney Stone
Oxidative Stress
Keywords: pharmacokinetic
lime powder regimen
kidney stone
Oxidative stress
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.


Eligibility criteria: Inclusion Criteria:

* Thai healthy male or female aged 18-45 years old
* BMI 18-25 kg/m2
* Normal medical history, physical examination and vital signs
* Normal screening laboratories
* no history of drug allergies
* Willingness to take part in the study and provide informed consent

Exclusion Criteria:

* History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
* History of alcohol or drug abuse
* Heavy smoking
* Receive any medication within 14 days prior to the study day

Primary outcomes:
measure: The pharmacokinetic parameters of plasma and urine citrate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chula clinical research center
Study officials:
affiliation: Chulalongkorn University
name: Poonsin Poungpairoj, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677325: The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
Official title: The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NAFLD( Non-alcoholic Fatty Liver Disease )
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.

Detailed description: 1) Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2) Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating levels of adipokines.

Eligibility criteria: Inclusion Criteria:

* subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of Hepatology, Chinese Medical Association, 2002.10),
* aged 18-65
* alcohol consumption less than 40g/week;
* liver/spleen (L/S) ratio no more than 1 by CT scan.

Exclusion Criteria:

* ALT more than twice the upper end of the normal range
* viral hepatitis
* total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease
* severe cardiovascular or renal dysfunction
* Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or postprandial glucose more than or equal to 11.1mmol/L)
* Subjects treated with statins

Primary outcomes:
measure: The CT ratio of liver/spleen
timeFrame: 12 weeks
Secondary outcomes:
measure: BMI(Body Mass Index )
timeFrame: 12 weeks
measure: liver function
timeFrame: 12 weeks
measure: lipid profile
timeFrame: 12 weeks
measure: NEFA(nonesterified fatty acid)
timeFrame: 12 weeks
measure: HOMA index
timeFrame: 12 weeks
measure: adiponectin
timeFrame: 12 weeks
measure: IL-6(interleukin 6)
timeFrame: 12 weeks
measure: hs-CRP (C-reactive protein)
timeFrame: 12 weeks
measure: TNFα( tumor necrosis factor-α)
timeFrame: 12 weeks
measure: leptin
timeFrame: 12 weeks
Other outcomes:
measure: renal function
timeFrame: 12 weeks
measure: Routine blood
timeFrame: 12 weeks
measure: Routine urine examination
timeFrame: 12 weeks
measure: Routine stool examination
timeFrame: 12 weeks
measure: electrocardiography
timeFrame: 12 weeks
measure: chest x-ray check
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Huashan Hospital, affliated to Fudan University
name: Wen-Jian Wang, Ph.D,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206825: Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers
Official title: Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Keywords: Electrocardiogram
Mobile ECG
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiac diseases,hospitalized in Department of Electrocardiology Medical University of Lodz as well as healthy volunteers will be enrolled to the study.

Brief summary: Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

Detailed description: Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

ECG evaluation will include: rhythm description, measurements of mean RR, PR, QRS, QT, QTc and ST-T description. Additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ECG and approximate from mobile ECG recordings.

Eligibility criteria: Inclusion Criteria:

* Patients with indication for electrocardiography
* Informed consent to participate in the study
* The possibility of self-registration of a mobile ECG (no physical and mental restrictions)

Exclusion Criteria:

* Not willing or incapable to give written informed consent.
* Lack of willingness to cooperate

Primary outcomes:
measure: ECG Tracing Quality
timeFrame: Once: Day 0-3 after entry to the study.
measure: Cardiac Rhythm Determination
timeFrame: Once: Day 0-3 after entry to the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Electrocardiology Medical University of Lodz
Study officials:
References:
Clinical trial NCT01287325: Efficacy of DNK333 in Patients With COPD and Cough
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Clinical Efficacy, Tolerability and Safety of Two Weeks Treatment With DNK333 100 mg Bid in Patients With COPD and Cough.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Cough
DNK333
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate COPD
* Forced expiratory volume in 1 second (FEV1) ≥30% predicted
* FEV1/FVC (forced vital capacity) \<70%
* Significant amount of cough and minimal amount of sputum production, both as judged by self reporting

Exclusion criteria:

* Upper or lower airway infection within 4 weeks prior to screening
* COPD exacerbation within 4 weeks prior to screening
* Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
* History of lung cancer or pulmonary resection/thoracic radiotherapy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Self-reported cough
timeFrame: At 2 weeks
Secondary outcomes:
measure: Sensitivity to capsaicin challenge
timeFrame: At 2 weeks
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06874725: Latent Tuberculosis in Type 2 Diabetes
Official title: Directly Observed Preventive Therapy (DOPT) for Latent Tuberculosis Infection Patients With Poorly Controlled Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Latent Tuberculosis Infection
Keywords: Latent tuberculosis infection
diabetes
observational study
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 552
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients with poorly controlled DM underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Detailed description: Poor control of diabetes mellitus (DM) increases active tuberculosis (TB) risk. Understanding risk factors for latent TB infection (LTBI) in this population is crucial for policy making. Under a collaborative multidisciplinary team consisting of endocrinologists and pulmonologists, patients with poorly controlled DM were enrolled; these patients underwent LTBI screening by using QuantiFERON (QFT). QFT-positivity predictors were evaluated. The patients with LTBI received tuberculosis preventive therapy, 9 months of daily isoniazid (9H) or 3 months of weekly rifapentine plus isoniazid (3HP), administered by pulmonologists. The completion rates and inflammatory markers were also investigated.

Eligibility criteria: Inclusion Criteria:

* aged ≥45 years
* poorly controlled DM (pDM), defined as HbA1c ≥9% within the preceding year

Exclusion Criteria:

* active TB
* immunocompromise (use of immunosuppressors
* current pregnancy

Primary outcomes:
measure: Brain-Derived Neurotrophic Factor
timeFrame: 9 months
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 9 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I-Te Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05407025: Targeting Inflammation for Endometrial Cancer Prevention
Official title: Targeting Inflammation for Endometrial Cancer Prevention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing hysterectomy at University of North Carolina (UNC) and Mayo Clinic, Florida

Brief summary: This study examines risk assessment and identifies prevention strategies for endometrial cancer. Collecting samples of blood and urine and risk assessments from patients with benign conditions or endometrial cancer may help doctors learn if there is a relationship between chronic inflammation and increase in risk for endometrial cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To develop a model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations.

OUTLINE: This is an observational study.

Patients complete a risk factor questionnaire over 15 minutes. Patients also undergo collection of blood and urine during pre-operative visit and collection of tissue samples at the time of surgery.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 years old undergoing hysterectomy for any benign indication or endometrial cancer

Exclusion Criteria:

* Men
* Women under the age of 18 years
* Women with a history of cancer, except for endometrial cancer or non-melanoma skin cancer
* Women with type 1 diabetes
* Women that have received radiation or chemotherapy for cancer

Primary outcomes:
measure: Levels of eicosanoids and specialized pro-resolving mediators (SPMs) in visceral adipose tissue (VAT)
timeFrame: Through study completion, up to 24 weeks
Secondary outcomes:
measure: Ribonucleic acid (RNA) expression pathways related to inflammation in VAT
timeFrame: Through study completion, up to 24 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mark E. Sherman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: