louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03083119: Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina
Official title: The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Heart Disease
Unstable Angina
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of coronary angiography unstable angina
* Clinical diagnosis of unstable angina
* Age of 30 to 75 years old
* Not use thrombolysis, dilate coronary drugs within two weeks
* Sign the consent

Exclusion Criteria:

* Severe valvular heart disease
* Insulin-dependent diabetes
* mental disease
* Combined with severe liver, kidney, hematopoietic system disorder
* Patients with malignant tumors
* Pregnancy or breast-feeding women
* Recent history of trauma
* Drug allergy

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 60 days
measure: Seattle Angina Questionnaire
timeFrame: 60 days
measure: blood stasis syndrome scale of Coronary heart disease angina pectoris
timeFrame: 60
Secondary outcomes:
measure: lipid
timeFrame: 60
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang Anmen Hospital
state: Beijing
Study officials:
affiliation: Guang Anmen Hospital
name: Jie Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan L, Liu Y, Li J, Zhang Y, Dong Y, Liu C, Wang J. Panax notoginseng Saponins Alleviate Coronary Artery Disease Through Hypermethylation of the miR-194-MAPK Pathway. Front Pharmacol. 2022 Jun 16;13:829416. doi: 10.3389/fphar.2022.829416. eCollection 2022.
Clinical trial NCT00728819: Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Official title: Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Keywords: Inpatients
Requiring
DL PICC
Access
Medications
Blood
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 339
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: TREATMENT

Brief summary: The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.


Eligibility criteria: Inclusion Criteria:

* All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of \> 2 weeks
* Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative

Exclusion Criteria:

* Skin related problems around the insertion site (infection, phlebitis, scars)
* History of mastectomy/axillary dissection on insertion side
* Coagulopathy with an INR of \> 2.0
* Thrombocytopenia with platelets \< 25,000 uL
* Renal insufficiency with a creatinine of \> 3.0 mg/dL
* Documented current upper extremity or central venous thrombosis
* Hypercoagulable states (protein C or S deficiency, AT-III deficiency, lupus anticoagulant)
* Catheters needed for therapy within less than an hour (emergent placement not allowing sufficient time for proper research consent and randomization)
* Patient has already been enrolled in this research study
* Life expectancy less than 1 month

Primary outcomes:
measure: Evidence of PICC-related Venous Thrombosis
timeFrame: 28 days, PICC removal or hospital discharge
Secondary outcomes:
measure: Post-operative Bleeding
timeFrame: Day 1
measure: Symptomatic PICC-related Venous Thrombosis
timeFrame: Procedure through 28 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Maxim Itkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Itkin M, Mondshein JI, Stavropoulos SW, Shlansky-Goldberg RD, Soulen MC, Trerotola SO. Peripherally inserted central catheter thrombosis--reverse tapered versus nontapered catheters: a randomized controlled study. J Vasc Interv Radiol. 2014 Jan;25(1):85-91.e1. doi: 10.1016/j.jvir.2013.10.009. Epub 2013 Nov 21.
Clinical trial NCT06273319: The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications
Official title: The Effect of Oxygen Administration With Double Nasal Cannula on Respiratory Complications in Endoscopies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Disease
Gastric Distress
Keywords: Desaturation
oxygen therapy
Sedoanalgesia
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.

Detailed description: Two groups of patients scheduled for gastrointestinal endoscopy will be compared in terms of desaturation and respiratory complications by applying 15 litres of oxygen therapy to the first group and 30 litres to the second group with double nasal cannula.

Eligibility criteria: Inclusion Criteria:

18-65 years old

PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY

Exclusion Criteria:

* Chronic obstructive pulmonary disease Having low saturation Lung cancer

Primary outcomes:
measure: Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu universitesi
Study officials:
References:
Clinical trial NCT05664919: Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk Populations
Official title: Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.

Detailed description: This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1\~2 times per day with an interval of 6 hours for about 30 days.

Eligibility criteria: Inclusion Criteria:

* Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
* Subjects were 18 years of age and older and in good health;
* Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.

Exclusion Criteria:

* Previous history of severe allergies or sensitivity to inhaled allergens;
* Women were pregnant or breastfeeding;
* Subjects were unable to cooperate with nasal spray inhalation;
* Other conditions for which medication was not appropriate.

Primary outcomes:
measure: COVID-19 infection rates
timeFrame: Up to 30 days(during case surveillance period)
Secondary outcomes:
measure: Infection rates of asymptomatic and symptomatic COVID-19 patients
timeFrame: Up to 30 days(during case surveillance period)
measure: Incidence of mild, normal, severe, and critical COVID-19 cases
timeFrame: Up to 30 days(during case surveillance period)
measure: The peak Ct value
timeFrame: Up to 30 days(during case surveillance period)
measure: Differences in the number of days of negative RT-PCR
timeFrame: Up to 30 days(during case surveillance period)
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia Fourth Hospital
state: The Inner Mongolia Autonomous Region
Study officials:
affiliation: Inner Mongolia Fourth Hospital
name: Shuo Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005419: Physical Activity, Hypertension, Diabetes, and Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus
Coronary Disease
Hypertension
Diabetes Mellitus, Non-insulin Dependent
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To study the influences of physical activity on the incidence of hypertension, non-insulin-dependent diabetes (NIDDM), and coronary heart disease (CHD), taking into account the influences of other life-style elements such as body size, cigarette habit, alcohol consumption habits, and parental history of disease on these same chronic diseases.

Detailed description: BACKGROUND:

Epidemiologic investigations of the influence of physical activity on the incidence of specific chronic diseases encounter problems of confounding or interaction with eating behavior, tobacco use, other social habits, and a host of personal characteristics. These influences of life styles on chronic diseases are not mutually exclusive, nor do they operate independently. Rather, they blend, amplifying or diminishing the effects of one another.

DESIGN NARRATIVE:

The study used data collected since 1960 as part of the College Alumni Health Study -- a cohort of 50,000 former students who attended Harvard College, 1916-1950, or the University of Pennsylvania, 1931-1940, and who reported by questionnaire on their health habits and health status in post-college years through 1988. Over 17,000 Harvard alumni have been followed from 1962 through 1988 for both non-fatal and fatal chronic diseases. These predictor (risk factors) and outcome (specific diseases) data were analyzed to test the hypothesis that different kinds and amounts (frequencies, intensities, durations, and constancies) of physical activity affect differently the incidence rates of hypertension, NIDDM, and CHD. Continuities and changes in specific life styles and chronic diseases have been measured continually through return-mail questionnaires in 1962, 1966, 1972, I977, and 1988. Cause-specific mortality has been monitored continuously over this span of time, 1962-1988. Using the data, the investigators computed relative and attributable risks of developing hypertension, NIDDM, and CHD that related to alumni patterns of physical activity, body size, alcohol consumption, cigarette use, and other personal characteristics and ways-of-living. In this discrete population, they searched for the relative importance of physical activity and other potential predictors in influencing the occurrence of these hypertensive-metabolic-atherosclerotic diseases.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06244719: Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation
Official title: Vibrotactile Stimulation for Neurological Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Stroke
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
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 investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:

Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?

Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.


Eligibility criteria: Inclusion Criteria:

* Inpatients at rehabilitation units
* Unilateral left or right sided ischemic stroke within the previous 2 weeks
* Have Upper-Extremity Fugl-Meyer scores between 6 and 58
* Have at least 20 degrees of active shoulder elevation and elbow flexion
* Expected to stay 1-3 weeks in the rehabilitation unit

Exclusion Criteria:

* Under anti-spasticity therapy
* Patients that are dependent on pacemakers
* Patients that have defibrillators
* Have lymphedema or AV fistula for dialysis on an arm

Primary outcomes:
measure: Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
timeFrame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Secondary outcomes:
measure: Number of participants with at least one adverse event
timeFrame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
measure: Number of participants who completed the therapy
timeFrame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
measure: Number of participants who tolerated the vibrotactile stimulation therapy
timeFrame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
measure: Change in the modified Ashworth scale
timeFrame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth Rehabilitation Unit
state: Colorado
city: Broomfield
country: United States
facility: Broomfield Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT04328519: The Charlson Comorbidity Index: Predicting Severity in Emergency Departments
Official title: The Charlson Comorbidity Index: Predicting Severity in Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Medicine
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to the emergency room

Brief summary: Objective: The Charlson Comorbidity Index (CCI) is a comorbidity scale used widely throughout the world. It uses patients' preoperative and intraoperative morbidity factors to evaluate morbidity and mortality risk. Though the CCI has widespread use, it has not been evaluated in patients attending at ES, and its relationship with patient readmission has not been shown previously. In this study, we aimed to show whether there is a correlation between the CCI value and the number of repeated admissions to emergency services and that the CCI value can be used as a predicted factor for the serious patients.

Matherials and Methods: This was a prospective observational cross-sectional study. Age, gender, vital signs of the patients who agreed to participate in the study was recorded. Numbers of emergency service applications in the last 6 months and CCI score have been recorded.

Detailed description: This study showed that CCI score can be used for identify serious patient in emergency service.

Eligibility criteria: Inclusion Criteria:

* Admitted patients were told about the study, and those who agreed to participate were included

Exclusion Criteria:

* Patients who did not wish to participate in the study
* Patients who were unable to work or who had problems with consciousness
* Patients with non-hospital cardiopulmonary arrest
* Patients who had previously participated in the study (readmitted patients)
* Patients who had accessed ES for the same or a similar complaint within the last seven days
* \< 18 years' old

Primary outcomes:
measure: determine the severity of patients. to identify patients who need hospitalization. determine the severity of patients.
timeFrame: 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Abdullah Osman Kocak
Study officials:
References:
Clinical trial NCT02433119: The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
Official title: A Multi-center, Randomized, Double-blind, Phase IV Clinical Trial to Compare the Efficacy and Safety of OROSARTAN® Tablet 5/160mg Versus CODIOVAN® Tablet 160/12.5mg in Patients With Essential Hypertension Uncontrolled With Valsartan 160mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 238
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy


Eligibility criteria: Inclusion Criteria:

* 19 aged or over
* A patient who was diagnosed with essential hypertension at screening(Visit 1)
* A patient understood objective of this clinical trial and gave their written informed consent voluntarily

Exclusion Criteria:

* A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
* A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
* Medical history or evidence of a secondary form of hypertension
* A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide

Primary outcomes:
measure: Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from baseline in MSDBP
timeFrame: Baseline, Week 4
measure: Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline, Week 4 and 8
measure: Control rate in blood pressure
timeFrame: Baseline, Week 8
measure: Responder rate in blood pressure
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
References:
Clinical trial NCT00886119: Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens
Official title: Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.


Eligibility criteria: Inclusion Criteria:

* Be at least 35 years of age.
* Best-corrected visual acuity of at least 20/40 in each eye.
* Spectacle add from +1.50D and +2.50D (inclusive).
* Able to be fit in available study sphere powers (Plano to -4.00D).
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol inclusion / exclusion criteria may apply.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Previous refractive surgery.
* Astigmatism \> 1.00D.
* Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
* Other protocol inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
timeFrame: After 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: