louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03249259: The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Official title: The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.

Detailed description: The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* baseline MMSE score 25-28

Exclusion Criteria:

* type 1 diabetes
* diabetes ketoacidosis or hyperosmolar hyperglycemic crisis
* HbA1c over than 9.0%
* MMSE less than 25
* abnormal TSH levels
* vitamin B12 deficiency
* severe infection, perioperative state, trauma
* hypopituitarism or adrenal insufficiency
* any conditions that lead to hospitalization
* chronic alcoholics within 1 year
* any drugs that can influence to cognitive function within 3 months

Primary outcomes:
measure: Cognitive function
timeFrame: 6 months
Secondary outcomes:
measure: Glucose metabolism
timeFrame: 6 months
measure: Glucose metabolism
timeFrame: 6 months
Other outcomes:
measure: Hypoglycemia
timeFrame: 6 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT01206959: Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff(Monitor When Being Inflated)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: BP
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2010-09-22
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital population, including patient and accompanies.

Brief summary: The purpose of this study is to monitor the blood pressure level of the patient using a blood pressure monitor which test the blood pressure level in inflating state . The cuff range in the study is 22cm-48cm


Eligibility criteria: Inclusion Criteria:

* cuff circumference:22cm-48cm

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06638359: Effects of Moderate Exercise And Interval Exercise On Sleep Quality
Official title: Effects of an Acute Bout of Moderate-Intensity Aerobic Exercise And High-Intensity Intermittent Exercise On Sleep During Night Shifts In Medical Shift Workers With Sleep Impairment: A Single-Blind Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Control Condition
Keywords: Heart rate variability
sleep quality
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.
Primary purpose: TREATMENT

Brief summary: This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.

Detailed description: Medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70\~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90\~95% of the maximum heart rate for 4 minutes and 50\~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. Sleep quality was assessed by ActiGraph with subjective questionnaire for 1 night and 3 nights after exercise. Tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.

Eligibility criteria: Inclusion Criteria:

* medical staff who have worked at least three consecutive night shifts
* reporting sleep disturbed during the night shift
* not taking sleep/psychotropic medications
* no clinical diagnosis of sleep apnea or other sleep disorder
* not exercising regularly

Exclusion Criteria:

* not medical staff
* without night shift
* taking sleep/psychotropic medications
* exercising regularly

Primary outcomes:
measure: total sleep time
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
state: North
Study officials:
affiliation: National Taiwan University of Sport
name: Sport research center
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351259: Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
Official title: Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mechanical Ventilation Complication
Tracheal Intubation Morbidity
Keywords: Mechanical ventilation
Intubation
Cuff pressure
Microaspiration
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

Detailed description: Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Eligibility criteria: Inclusion Criteria:

* Patients requiring intubation in the ICU
* Predicted duration of mechanical ventilation \> or = 48h
* Age \> or = 18 years

Exclusion Criteria:

* Contraindication for semirecumbent position
* Contraindication for enteral nutrition
* Pregnancy

Primary outcomes:
measure: Percentage of patients with underinflation or overinflation of cuff pressure
timeFrame: 48 h
Secondary outcomes:
measure: Impact of tracheal-cuff shape on variations in cuff pressure
timeFrame: 48 h
measure: Impact of continuous control of cuff pressure on microaspiration of gastric contents
timeFrame: 48 h
measure: Impact of tracheal cuff shape on microaspiration of gastric contents
timeFrame: 48 h
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Calmette Hospital, CHU de Lille
state: Nord
Study officials:
affiliation: CHU de Lille
name: Saad NSEIR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.
Clinical trial NCT00360659: Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea Before and After Treatment With CPAP.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep Apnea
Hypertension
Vasoactive hormones
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 65 years
* Obstructive sleep apnea
* Hypertension or normal blood pressure

Exclusion Criteria:

* Drug or alcohol abuse
* Pregnancy
* History or clinical signs of disease in the heart, lungs, brain,liver, kidneys or endocrine organs
* Diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
state: Ringkoebing County
Study officials:
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06257459: Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy
Official title: Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy in Infertile Men With Oligo-asthenzoospermia: A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Infertility
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery

Detailed description: This will be a prospective randomized study, in which adult infertile patients with clinical varicocele and oligo-athenospermia admitted to Urology department Tanta university hospital will be included and then the patients with detected spermatic cord lipoma at the time surgery will be enrolled and divided into 2 groups:

GROUP A : will undergo subinguinal varicocelectomy with excision of spermatic cord lipoma GROUP B : will undergo subinguinal varicocelectomy with preservation of spermatic cord lipoma

Inclusion criteria:

* Adult infertile males
* Clinical varicocele
* oligo-asthenospermia

Exclusion criteria:

* Adolescent varicocele
* Recurrent varicocele
* Presence of inguinal hernia
* Azospermic patients

Eligibility criteria: Inclusion Criteria:

* Adult infertile males
* Clinical varicocele
* Semen analysis show oligo-athenospermia

Exclusion Criteria:

* Adolescent varicocele
* Recurrent varicocele
* Presence of inguinal hernia
* Azospermic patients

Primary outcomes:
measure: semen parameters improvement
timeFrame: 3 and 6 months after surgery
measure: symptoms improvement (pain and swelling)
timeFrame: 3 and 6 months after surgery
Secondary outcomes:
measure: postoperative complications
timeFrame: early after surgery and late
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ahmed Zoeir
state: Gharbeya
Study officials:
References:
Clinical trial NCT05421559: Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy
Official title: Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid
Surgery
Thyroid Disease
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 122
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The sternothyroid (ST) muscle is closely adherent to the thyroid gland with oblique insertion into the thyroid cartilage. EBSLN passes through the sternothyroid laryngeal triangle with a parallel course deep to the ST muscle.

This study evaluates the transection of the sternothyroid muscle as a key step during thyroidectomy to increase the rate of exposure and visual identification of EBSLN compared to ST muscle retraction as a traditional technique.

Detailed description: The study was conducted on patients eligible for total thyroidectomy, which meets the standard of the ATA Thyroid Guidelines. Preoperative biochemical thyroid function tests and neck ultrasound with FNAC of suspicious nodules confirmed the clinical diagnosis. Patients who had previously undergone neck surgery or irradiation or were preoperatively diagnosed with a vocal cord movement disorder, a vocal cord benign lesion, or speech disorders were excluded from the study. A random number was used to determine the patient group allocation.

Data about patients were gathered via history, examinations, and investigations. The patients were randomized (computer-generated) with the use of an opaque-sealed envelope into two groups; group A: conventional method of thyroidectomy with ST muscle retraction, group B: transection of ST muscle.

The study's primary endpoint was the identification rate of the EBSLN in both techniques. The secondary endpoints included: a comparison of operative time in both techniques as well as anatomical variability of the EBSLN according to Cernea classification, rate of injury of EBSLN, and changes in postoperative voice performance.

Eligibility criteria: Inclusion Criteria:

* eligible for total thyroidectomy
* no previous history of neck surgery or radiation
* no vocal cord pathology
* no voice disorders

Exclusion Criteria:

* not fit for surgery
* previous history of neck surgery or radiation
* vocal cord pathology
* vocal cord movement disorders

Primary outcomes:
measure: rate of identification and exposure of the external laryngeal nerve during thyroidectomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr Al Sheikh
Study officials:
References:
Clinical trial NCT05018559: Physical Activity-related Health Competence in Apprenticeship and Vocational Education
Official title: Physical Activity-related Health Competence in Apprenticeship and Vocational Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: physical activity promotion
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2021-08-24
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although the health-promoting effects of physical activity are well known and apprentices often possess an insufficient amount of physical activity, there is a lack of interventions promoting physical activity in vocational education and training. Against this background, the PArC-AVE project uses a co-creation approach to develop and implement physical activity-promoting interventions tailored to the needs of the target group and the given setting in two vocational education and training institutions. The purpose of this study is to evaluate the effectiveness of the co-created interventions in vocational education and training, namely the BuG lesson in nursing care and the tutoring system in automotive mechatronics. Therefore, the investigators conducted two non-randomized controlled trials from October 2018 to September 2019.


Eligibility criteria: Inclusion Criteria:

* First-year apprentices from the automotive mechatronics and nursing care sectors

Exclusion Criteria:

* /

Primary outcomes:
measure: Changes in self-reported physical activity: BSA questionnaire
timeFrame: Baseline and 6 to 9 months
measure: Changes in physical activity-related health competence: BGK Questionnaire
timeFrame: Baseline and 6 to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-University Erlangen-Nürnberg
Study officials:
affiliation: Friedrich-Alexander-University Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grune E, Popp J, Carl J, Semrau J, Pfeifer K. Examining the sustainability and effectiveness of co-created physical activity interventions in vocational education and training: a multimethod evaluation. BMC Public Health. 2022 Apr 15;22(1):765. doi: 10.1186/s12889-022-13133-9.
Clinical trial NCT03056859: Compass Device CVC Trial
Official title: Central Venous Catheterization in Obese Patients With Compass Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: Operator satisfaction with device
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Centurion Medical Products
First posted: 2017-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.

Brief summary: This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.

Detailed description: Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture.

Eligibility criteria: Inclusion Criteria:

* BMI ≥35

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Non-English speakers
* Prisoners

Primary outcomes:
measure: Operator Satisfaction
timeFrame: 15 minutes
Secondary outcomes:
measure: Arterial Puncture Incidence
timeFrame: 15 minutes
measure: Implement Used at Time of Arterial Puncture, if Any
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico School of Medicine
name: Neal Gerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792059: DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction
Official title: DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2023-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)

Brief summary: Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients.

Transthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction.

These diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist.

The aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.


Eligibility criteria: Inclusion Criteria:

* Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)

Exclusion Criteria:

* Morbid obesity;
* Any chronic diseases in the stage of exacerbation and / or decompensation;
* Systemic diseases, cancer;
* Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms;
* History of myocardial infarction, stroke, heart failure with reduced ejection fraction;
* Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy;
* Congenital and acquired heart defect;

Primary outcomes:
measure: An increased of post-exercise E/e' ratio
timeFrame: during diastolic stress test (baseline)
measure: An increased of post-exercise pulmonary artery systolic pressure (PASP)
timeFrame: during diastolic stress test (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Therapy and Preventive Medicine
Study officials:
References: