louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02151734: Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchitis
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 242
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.

The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 12-75 years old
* A total score of BSS ≥ 5
* The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
* Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria:

* Indication for antibiotic treatment(e.g. severe respiratory infection)
* Allergic bronchial asthma
* Tendency to bleed
* Severe heart, renal, or liver diseases or decline of immune function
* Chronic obstructive pulmonary disease
* Known or supposed hypersensitivity to investigational medication
* Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
* Women during pregnancy or lactation period
* Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
* Participation in any other trial within 30 days prior to inclusion in the trial
* Unsuitable patients for enrollment in the opinion of the investigator

Primary outcomes:
measure: Total score of BSS(Bronchitis Severity Score)
timeFrame: 7days
Secondary outcomes:
measure: Individual symptom score of BSS
timeFrame: 7days
measure: reaction rate of treatment
timeFrame: 7days
measure: IMOS(Integrative Medicine Outcome Scale)
timeFrame: 7days
measure: IMPSS(Integrative Medicine Patient Satisfaction Scale)
timeFrame: 7days
measure: Adverse events, clinical laboratory examination, physical examination, etc.
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04625634: Simulation of Consecutive Day Shift Work
Official title: Simulation of Consecutive Day Shift Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Fatigue; Heat
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures study
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.


Eligibility criteria: Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* Current tobacco use or regular use within the last 2 years
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
* History of exertional heat stroke
* Currently pregnant or breastfeeding, or planning to become pregnant during the study
* Inability to follow the rules of the protocols or understand the consent form
* No contraindications for ingestion of the gastrointestinal temperature pill

Primary outcomes:
measure: Core temperature
timeFrame: 20 minutes
measure: Heart rate
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Exercise in Special Environments
state: New York
Study officials:
References:
Clinical trial NCT00102934: Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Official title: Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Drug Resistance
Viral Fitness
HIV Specific Immunity
T Cell Activation
Drug Resistant Viremia
Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

Detailed description: While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus.

This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.

Eligibility criteria: Inclusion Criteria:

* HIV viral load of more than 1000 copies/ml
* On stable antiretroviral therapy
* Have multidrug resistance

Exclusion Criteria:

* Require immunomodulatory drugs

Primary outcomes:
measure: HIV viral load
timeFrame: Throughout study
Secondary outcomes:
measure: Frequency of HIV-specific T cells
timeFrame: Thoughout study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: Department of Medicine, University of California - San Francisco
name: Steven G. Deeks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04434534: Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness
Official title: Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: Endhothelial function
Anthocyanins
Arterial stiffness
Açaí Juçara
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial stiffness in overwheight and obese individuals. Half of participants will receive a hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will receive just a hipocaloric diet.

Detailed description: Obesity is the most prevalent nutritional disease and a growing public health problem worldwide. This clinical condition is an established risk factor for cardiovascular diseases.

Açaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have antioxidative and vasodilatory properties. Prospective studies have shown that the antioxidant present in berries can improve vascular health, like endothelial function, measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave Velocity (PWV).

Eligibility criteria: Inclusion Criteria:

* Sedentary lifestyle
* Overwheight or obesity "1" diagnostic (BMI \>25kg/m² and \<35kg/m²)

Exclusion Criteria:

* Alcoolism
* Smoking
* Diagnostic of Diabetes Mellitus or Coronary Artery Disease
* Use of Statin Therapy
* Cardiovascular diseases
* Infectious Disease

Primary outcomes:
measure: Flow-mediated Dilation (FMD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Pulse Wave Velocity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia
name: Tainah Ortiz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05425134: Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical N0 Lung Cancer
Official title: PET/CT-based Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical Stage N0 Non-Small Cell Lung Cancer: A Multicenter Prospective Diagnostic Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer
Lymph node metastasis
Deep learning
PET-CT
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Nanchang University
First posted: 2022-06-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinica N0 Non-small Cell Lung Cancer

Brief summary: The purpose of this study is to evaluate the performance of a PET/CT-based deep learning signature for predicting occult nodal metastasis of clinical stage N0 non-small cell lung cancer in a multicenter prospective cohort.


Eligibility criteria: Inclusion Criteria:

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) The maximum short-axis diameter of N1 and N2 lymph nodes less than 1 cm on CT scan; (3) The SUVmax of N1 and N2 lymph nodes less than 2.5; (4) Pathological confirmation of primary NSCLC; (5) Age ranging from 20-75 years; (6) Obtained written informed consent.

Exclusion Criteria:

(1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants not receiving systematic lymph node dissection; (5) Participants who have received neoadjuvant therapy.

Primary outcomes:
measure: Area under the receiver operating characteristic curve
timeFrame: 2022.1-2023.12
Secondary outcomes:
measure: Sensitivity Sensitivity
timeFrame: 2022.1-2023.12
measure: Specificity
timeFrame: 2022.1-2023.12
measure: Positive predictive value
timeFrame: 2022.1-2023.12
measure: Negative predictive value
timeFrame: 2022.1-2023.12
measure: Accuracy
timeFrame: 2022.1-2023.12
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yangpu
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Ningbo
country: China
facility: Ningbo HwaMei Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03406234: Observational Study on a Chinese Population
Official title: Observational Study on the Risk Factors for Health in a Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Nutrition Disorders
Genetic Predisposition to Disease
Lead sponsor: Shenzhen Center for Chronic Disease Control
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 2650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both males and females were included.

Brief summary: An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population.


Eligibility criteria: Inclusion Criteria:

* Han population, living in Shenzhen City for \> 2 y, not in pregnancy, without hepatic diseases and renal diseases

Exclusion Criteria:

* caught by organic diseases

Primary outcomes:
measure: Circulating 25OHD concentration.
timeFrame: Jan., 2014 - May., 2015
Secondary outcomes:
measure: Body mass index
timeFrame: Jan.-Dec., 2013
measure: Plasma glucose
timeFrame: Jan.-Dec., 2013
measure: DNA polymorphisms
timeFrame: Jan., 2014 - Dec., 2017
measure: Plasma lipids
timeFrame: Jan.-Dec., 2013
measure: Blood pressure
timeFrame: Jan.-Dec., 2013
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Center for Chronic Disease Control
state: Guangdong
Study officials:
References:
citation: Chen J, Yun C, He Y, Piao J, Yang L, Yang X. Vitamin D status among the elderly Chinese population: a cross-sectional analysis of the 2010-2013 China national nutrition and health survey (CNNHS). Nutr J. 2017 Jan 14;16(1):3. doi: 10.1186/s12937-016-0224-3.
citation: Santos BR, Mascarenhas LP, Boguszewski MC, Spritzer PM. Variations in the vitamin D-binding protein (DBP) gene are related to lower 25-hydroxyvitamin D levels in healthy girls: a cross-sectional study. Horm Res Paediatr. 2013;79:162-8. doi: 10.1159/000348847. Epub 2013 Mar 20.
citation: Gozdzik A, Zhu J, Wong BY, Fu L, Cole DE, Parra EJ. Association of vitamin D binding protein (VDBP) polymorphisms and serum 25(OH)D concentrations in a sample of young Canadian adults of different ancestry. J Steroid Biochem Mol Biol. 2011 Nov;127(3-5):405-12. doi: 10.1016/j.jsbmb.2011.05.009. Epub 2011 Jun 12.
citation: Zhou JC, Zhu Y, Gong C, Liang X, Zhou X, Xu Y, Lyu D, Mo J, Xu J, Song J, Che X, Sun S, Huang C, Liu XL. The GC2 haplotype of the vitamin D binding protein is a risk factor for a low plasma 25-hydroxyvitamin D concentration in a Han Chinese population. Nutr Metab (Lond). 2019 Jan 14;16:5. doi: 10.1186/s12986-019-0332-0. eCollection 2019.
Clinical trial NCT02160834: Reducing Sedentary Time in Obese Adults (Study 2)
Official title: A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Sedentary behavior
Physical activity
Obesity
Mobile health
Smartphone
Time spent sedentary
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Eligibility criteria: Inclusion Criteria:

* Bariatric surgery patients and other obese individuals will be considered
* Body mass index \>= 25 kg/m2

Exclusion Criteria:

* Report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance
* Are currently involved in a physical activity intervention.
* Are unable to read or understand the study materials
* Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
* Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.

Primary outcomes:
measure: Change in percentage of daily sedentary time from baseline to post-intervention.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in percentage of daily sedentary time from baseline to follow-up
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital/Brown Alpert Medical School
name: Dale S Bond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165134: Hallux Valgus Conservative Treatment
Official title: Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2021-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest and posttest Control group randomized control trial
Primary purpose: TREATMENT

Brief summary: Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.

Detailed description: 30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups

1. st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.
2. nd group receive placebo tape bilaterally and had the same measurements.

2 groups were on a group of exercises

Eligibility criteria: Inclusion Criteria:

* mobile hallux valgus

Exclusion Criteria:

* using orthotics
* knee malalignment

Primary outcomes:
measure: Hallux valgus angle (HVA )
timeFrame: 8 weeks
measure: Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gizan
country: Saudi Arabia
facility: Jazan University
state: Jazan
Study officials:
affiliation: Assistant Professor of physical therapy
name: Mohamed M Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687334: Changes of Cerebral Oxygenation During Anesthesia Induction
Official title: Changes of Cerebral Oxygenation During Anesthesia Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygen Saturation
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients scheduled for elective radical operations for mastocarcinomaat in the First Hospital of China Medical University will be recruited for the study

Brief summary: The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.

Detailed description: The aim of this study was to investigate the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of anesthesia induction.

Eligibility criteria: Inclusion Criteria:

* Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma.

Exclusion Criteria:

* Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.

Primary outcomes:
measure: changes of cerebral oxygen saturation
timeFrame: Baseline and 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: the First Hoapital of China Medical University
name: Wen-fei Tan, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: