louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06076044: Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects
Official title: Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Motor Evoked Potential
Healthy Subjects
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age ranges from 20 to 30 years old
* No history of neurological or psychiatric diseases, no history of chronic illness
* No positive results were found in the examination of the nervous system
* All right-handed according to Edinburgh Handedness Inventory
* The subjects voluntarily participated in this study and signed an informed consent form

Exclusion Criteria:

* Individuals with severe illnesses
* Previous history of brain surgery or epilepsy
* Individuals who experience changes in physical condition during the experiment
* Individuals with metal implants, such as pacemakers, DBS therapists, stents, etc
* Alcoholics

Primary outcomes:
measure: MEP
timeFrame: before treatment and 20, 30, 40, 50, 60 minutes after treatment
measure: Power Spectral Density of EEG
timeFrame: before treatment and right after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT05849844: Tympanoseal Clinical Study
Official title: Tympanoseal (Tympanic Membrane Device) Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tympanic Membrane Perforation
Lead sponsor: Grace Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

Detailed description: This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients over 2 years of age at enrollment
2. Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion Criteria:

1. Active otorrhea or otitis media
2. Otorrhea or otitis media within 4 weeks prior to the operation
3. History of cholesteatoma
4. Perforations on the edge of the tympanic membrane
5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
6. Subject is taking systemic/oral corticosteroids
7. Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Primary outcomes:
measure: Number of participants with healed tympanic membrane perforations.
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: Memphis
country: United States
facility: Methodist Le Bonheur
state: Tennessee
Study officials:
References:
Clinical trial NCT06905444: Effects of Multimodal Therapy Versus Myofascial Release Techniques in Patient With Upper Cross Syndrome
Official title: Effects of Multimodal Therapy Versus Myofascial Release Techniques in Patient With Upper Cross Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Upper Extremity Dysfunction
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Upper Cross Syndrome (UCS) is a frequent condition which is most commonly encountered in the musculoskeletal disorders showing a characteristics pattern of muscular imbalance and dysfunction in the joints of the neck and shoulder region. Upper Cross Syndrome remains a prevalent and debilitating condition, despite optimal approaches aimed at reducing pain and improving function.

Detailed description: This study investigates the additional benefits of Multimodal Therapy and Myofascial Release Technique in individuals with Upper Cross Syndrome. Rooted .The researcher employs a randomized controlled trial methodology. Participants are divided into two groups: one receiving Multimodal Therapy, and the other receiving Myofascial Release Techniques. Outcomes are assessed over a 6-week period, focusing on pain levels, Posture and functional disability by goniometer, Numeric pain rating scale (NPRS), Neck disability index (NDI) scores and REEDCO posture assessment scale.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by physician with sign and symptoms includes muscle in neck, chest and shoulder become overactive or underactive creating the X shape.
* Office worker.
* Aged 20 to 40 years.
* Male and females.

Exclusion Criteria:

* Recent trauma or surgery to the neck or shoulder region.
* Cancer or Metastasis in the neck or shoulder region.
* Infection or Abscess in the neck or shoulder region.
* Neurological conditions.

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE (NPRS)
timeFrame: 12 Months
measure: NECK DIABILITY INDEX (NDI)
timeFrame: 12 Months
measure: REEDCO POSTURE ASSESSMENT SCALE
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: Alkhidmat hospital Sahiwal
state: Punjab
Study officials:
References:
Clinical trial NCT02016144: Optimal Length of Pre-inserted ETT for Nasal Fiber Optic Intubation
Official title: Optimal Length of the Pre-inserted Endotracheal Tube for Obtaining Good View of Laryngeal Opening for Nasal Fibreoptic Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Fiberoptic Intubation
Keywords: Airway management; Fiber optic technology; Intubation
Lead sponsor: Seoul National University Dental Hospital
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo an elective oral and maxillofacial surgery requiring a nasal intubation of ETT for general anesthesia

Brief summary: This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic intubation and the equation to predict it.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* aged 20-65 yr (adults)

Exclusion Criteria:

* rhinitis
* bleeding diatheses
* requirement of awake intubation
* a previous major oral and maxillofacial surgery history
* anatomical deformity of the face, neck and upper airway

Primary outcomes:
measure: optimal length of pre-inserted ETT for nasal fiberoptic intubation
timeFrame: during endotracheal intubation for general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Dental Hospital
Study officials:
affiliation: Seoul National University Dental Hospital
name: Jung-Man Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693744: Pseudoexfoliation and Chronic Kidney Disease
Official title: The Relationship Between Pseudoexfoliation and Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Pseudoexfoliation, chronic kidney disease
Lead sponsor: Corum State Hospital
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 358
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from nephrology clinic

Brief summary: Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.

Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients, group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal kidney functions (control group). Demographic properties and the rate of PEX were evaluated and compaired between the groups.


Eligibility criteria: Inclusion Criteria:

* All patients with chronic kidney disease stage 1-5

Exclusion Criteria:

* History of eye trauma or surgery

Primary outcomes:
measure: Prevalance of pseudoexfoliation in patients with chronic kidney disease
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Corum State Hospital
Study officials:
affiliation: Specialist in Ophthalmology
name: Leyla Niyaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02035644: Study on the Efficacy aNd Safety of Jinlida Granules in Patients With Inadequately cOntrolled tYpe-2 Diabetes and dysLIpidemia Under liFe Style Intervention (ENJOY LIFE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Dyslipidemia
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shijiazhuang Yiling Pharmaceutical Co. Ltd
First posted: 2014-01-14
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention.


Eligibility criteria: Inclusion Criteria:

1. age of 20-70 years;
2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
3. HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/L at baseline;
4. diagnosed with dislipidemia with triglycerides\>150mg/dL (1.70mmol/L), and/or total cholesterol \>200mg/dL (5.16mmol/L), and/or LDL-c\>100mg/dL (2.58mmol/L)
5. body mass index (BMI): 20\<BMI\<40 kg/m2;

Exclusion Criteria:

1. moderate or severe liver dysfunction, abnormal renal function;
2. severe dysfunction of the heart;
3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
4. psychiatric disease or severe infection;
5. pregnancy or planned pregnancy;
6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
7. use of chronic (\>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
9. history of malignant tumor within 5 years.

Primary outcomes:
measure: change in HbA1c levels
timeFrame: 16 weeks
Secondary outcomes:
measure: fasting, postload 30-min and 2-h plasma glucose
timeFrame: 16 weeks
measure: fasting, postload 30-min and 2-h serum insulin
timeFrame: 16 weeks
measure: serum lipids
timeFrame: 16 weeks
measure: glucose disposal rate (GDR) values from hyperinsulinemic euglycemic clamp
timeFrame: 16 weeks
measure: incretins
timeFrame: 16 weeks
measure: metabolomic parameters
timeFrame: 16 weeks
measure: BMI
timeFrame: 16 weeks
measure: blood pressures
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Guang Ning
state: Shanghai
Study officials:
References:
Clinical trial NCT05143944: Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project
Official title: Audit of Management of First Stage of Labour in Assiut University Hospitals : a Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Delivery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal vaginal dellivary of primigravida

Brief summary: auditing the current management of first stage of normal vaginal deliveries at Assiut university hospitals emergency obstetric care

Detailed description: Clinical auditing is a quality improvement process that involves reviewing the delivery of healthcare to ensure the best practice is being carried out . it is agreed that caesarean section rates are above the nationally accepted in Egypt . This can be related to many factors and can be associated with risks to morbidities and mortalities

Eligibility criteria: Inclusion Criteria:

* term 37- 41 weeks primigravida single vertex presentation living fetus spontaneous onset no contraindications for vaginal delivary

Exclusion Criteria:

* women with associated co morbidities pre eclampsia and diabetes IUFD previous uterine scar intrauterine growth restriction

Primary outcomes:
measure: measure performance according to gold standers
timeFrame: BASELINE
Secondary outcomes:
measure: introduction of NICE guidelines in practice
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02702544: Effect of Passive Leg Raising for Fluid Responsiveness
Official title: Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Fluid Retention
Impedance
Cardiac Output, Low
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* no clinical cardiovascular disease during the 6 months proceeding entry

Exclusion Criteria:

* not meet above criteria
* episode of illness (for example: infection)
* pregnancy

Primary outcomes:
measure: Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation
timeFrame: 1 day
Secondary outcomes:
measure: Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation
timeFrame: 1 day
measure: Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation
timeFrame: 1 day
measure: Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation
timeFrame: 1 day
measure: Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation
timeFrame: 1 day
measure: Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation
timeFrame: 1 day
measure: Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
affiliation: Medical University of Warsaw
name: Lukasz Szarpak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086340: Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
Official title: Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast neoplasm
Hormone receptor-positive Human epidermal growth factor receptor 2 negative (HR+,HER2-)
palbociclib
Metastatic
Medicare
SEER-Medicare
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 779
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medicare recipients with HR+/HER2- with De Novo metastatic breast cancer

Brief summary: A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States


Eligibility criteria: Inclusion Criteria:

* De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
* HR+/HER2- molecular subtype at diagnosis
* Initiated 1L systemic therapy with palbociclib + AI or AI alone

Exclusion Criteria:

* Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.

Primary outcomes:
measure: Overall Survival
timeFrame: From 1 February 2015 through 31 December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer New York
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04704440: Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: hypoxia
exercise
Sildenafil
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: mean pulmonary artery pressure (mPAP) / cardiac output (CO)
timeFrame: 4 hours
Secondary outcomes:
measure: Differences in pulmonary arterial pressure
timeFrame: 4 hours
measure: Differences in cardiac output
timeFrame: 4 hours
measure: Differences in pulmonary vascular resistance
timeFrame: 4 hours
measure: Differences in pulmonary artery wedge pressure
timeFrame: 4 hours
measure: Differences in right atrial pressure
timeFrame: 4 hours
measure: Differences in mixed venous oxygen saturation
timeFrame: 4 hours
measure: Differences in heart rate
timeFrame: 4 hours
measure: Differences in blood pressure
timeFrame: 4 hours
measure: Differences in oxygen saturation
timeFrame: 4 hours
measure: Differences in arterial blood gases
timeFrame: 4 hours
measure: Differences in mixed venous blood gases
timeFrame: 4 hours
measure: Differences in cerebral tissue oxygenation
timeFrame: 4 hours
measure: Differences in muscle tissue oxygenation
timeFrame: 4 hours
measure: Differences in symptoms (Borg dyspnoea)
timeFrame: 4 hours
measure: Differences in symptoms (Borg leg effort)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversityHospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: