louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04937621: Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19
Official title: Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
SARS-CoV-2 Infection
Keywords: COVID-19
ECG
Torsade de pointe
QT interval
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with SARS-CoV-2 infection followed by Bordeaux University Hospital for COVID-19

Brief summary: Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de pointe. The investigators therefore create a study that include all patients with SARS-CoV-2 infection having an electrocardiogram (ECG). The investigators evaluate the percentage of patients with ECG abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected QT (cQT) interval modification in patients receiving treatment.

Detailed description: In patients with SARS-CoV-2 infection, the investigators analyze baseline ECG as well as follow-up ECG. Patients followed by Bordeaux University Hospital for COVID-19 can be included. ECG are digitized in the computerized patient file (DxCARE) for further analysis.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of both gender,
* Followed by Bordeaux University Hospital for SARS-CoV-2 infection with a cardiac monitoring or ECG realized.
* Non opposition expressed.

Exclusion Criteria:

* Minor,
* Inability to understand the study

Primary outcomes:
measure: Proportion of ECGs abnormalities in patients SARS-CoV-2 infection
timeFrame: Day 0
Secondary outcomes:
measure: Evolution of PR, QRS and cQT interval
timeFrame: Baseline and 1 month
measure: Rate of syncope during treatment
timeFrame: Baseline and 1 month
measure: Rate of cardiac death during treatment
timeFrame: Baseline and 1 month
measure: Rate of arrhythmia during treatment
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: frédéric Sacher, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03147521: Accidental Falls Care Bundle
Official title: Stepped Wedge Cluster Randomized Controlled Trial for the Evaluation of Effectiveness of a Accidental Falls Care Bundle Implementation in Elderly Hospital Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Accidental falls represents an elderly very important health problem, both in the community and within the hospital. The aim of this research project is to evaluate the effectiveness of accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and rehabilitation wards, in terms of incidence and outcome reduction. It will be also investigated the cost effectiveness ratio, in terms of falls avoided, care bundle implementation costs, and falls related healthcare costs. The study will permit to evaluate the implementation feasibleness in time, considering the study will last for 20 months.


Eligibility criteria: Inclusion Criteria:

* Patients with ≥ 75 years of age with or without documented fall risk and patients with \< 75 years of age, but ≥ 18, only at documented fall risk, admitted at participant wards. The risk assessment will be performed with Conley scale and/or on the base of some specific fall risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption);
* Patients (or legal guardian for those incapable of giving their consent) that give their consent to the study participation .

Exclusion Criteria:

* Patients or legal guardian that don't give their consent to study participation.

Primary outcomes:
measure: Falls Incidence rate
timeFrame: 5 months
Secondary outcomes:
measure: Falls outcome
timeFrame: 5 monts
measure: Cost-effectiveness
timeFrame: 20 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04430621: Effects of FSH on Endothelial Function (FEND)
Official title: Effects of Follicle-Stimulating Hormone Injection on Flow Mediated Dilation in Healthy Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Change in Flow Mediated Dilation
Keywords: endothelial function, atherosclerosis, FSH, FMD
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affect endothelial function.

Detailed description: The effects of follicle-stimulating hormone (FSH) have been poorly studied. In women, FSH is involved in estrogen production, while in men regulates spermatogenesis. On the other hand, in women, menopause is associated with an increase in the risk of cardiovascular disease and the concentration of FSH rises. It is unclear whether such an increase has any effect on the development of atherosclerosis. Endothelial dysfunction represents an early trigger of atherosclerosis. Since estrogens can directly stimulate endothelial function and increase in response to FSH administration, males might represent a potential model to study the effcts of FSH independent from estrogens.Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affects endothelial function.

Eligibility criteria: Inclusion Criteria: Healthy volunteers -

Exclusion Criteria:

-

Primary outcomes:
measure: Change in flow mediated dilation
timeFrame: before and 48 hours after FSH or placebo administration
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Internal Medicine and Diabetes Unit
Study officials:
affiliation: University Federico II
name: Raffaele Napoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963021: NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Major Depressive Disorder
NBI-1065845
TAK-653
MADRS
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 200
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: The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.


Eligibility criteria: Key Inclusion Criteria:

* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Primary outcomes:
measure: Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
timeFrame: Baseline, Day 56
Secondary outcomes:
measure: Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
timeFrame: Baseline, Day 56
measure: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
timeFrame: Baseline, Day 56
Other outcomes:
Locations:
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT03724721: Pneumothorax Drainage With Vacuum Bottle
Official title: To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iatrogenic Pneumothorax
Vacuum Bottle Assisted Needle Aspiration
Keywords: Pneumothorax/therapy
Drainage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Detailed description: For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Eligibility criteria: 1. Inclusion criteria:

   · Clinical diagnosis of pneumothorax
2. Exclusion criteria

   * Bleeding tendency
   * Tension pneumothorax
   * Shock

Primary outcomes:
measure: Intrapleural pressure during vacuum bottle air drainage
timeFrame: Within 1 hour
Secondary outcomes:
measure: Rate of reexpansion pulmonary edema
timeFrame: within 1day after the procedure
measure: The resolution rate of pneumothorax
timeFrame: 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Kuo Yao-Wen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chen Shih-Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen SY, Kuo YW, Ho CC, Wu HD, Wang HC. Safety and efficacy of vacuum bottle plus catheter for drainage of iatrogenic pneumothorax. BMC Pulm Med. 2022 Jun 7;22(1):221. doi: 10.1186/s12890-022-02009-8.
Clinical trial NCT01443221: Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Official title: Open-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: mitiglinide
metformin
Pharmacokinetics
Safety
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Detailed description: The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.

Eligibility criteria: Inclusion Criteria:

* Healthy males
* Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.)
* Subject with normal results in blood pressure, pulse, body temperature and ECG test
* Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion Criteria:

* Clinically significant functional disorder or acute disease
* Chronic disease affecting the absorption, metabolism or excretion of drug
* Any study drug administration within 90 days before the first drug administration
* Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration

Primary outcomes:
measure: Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers
timeFrame: Up to 36 hours postdose for each period
Secondary outcomes:
measure: Compare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers
timeFrame: Up to 36hours postdose for each period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Hur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173921: The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area
Official title: Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: Dental implant
Robotic system
Static navigation system
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Detailed description: Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Eligibility criteria: Inclusion Criteria:

* Informed consent form signed voluntarily.
* Aged at least 18 years.
* Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
* Sufficient bone volume for implant placement without bone augmentation;
* The minimum number of residual teeth was seven teeth.
* Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.

Exclusion criteria:

* Systemic disease that would interfere with dental implant surgery.
* Bisphosphonate treatment.
* Untreated, uncontrolled periodontal disease.
* Heavy smoker (more than 10 cigarettes per day).
* Poor oral hygiene.

Primary outcomes:
measure: implant positional accuracy
timeFrame: immediately after surgery
Secondary outcomes:
measure: Pain perception
timeFrame: immediately after surgery, and 1 to 7 days after surgery.
measure: Surgery complication
timeFrame: Immediately and 7 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04849221: Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage
Official title: Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 41
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: Head trauma patient operated on for an intracranial lesion or other condition (hemorrhagic stroke)

Brief summary: Intracranial pressure is usually measured by invasive methods requiring an intracranial sensor. There is no non-invasive monitoring method recognized as a gold standard. Tympanometry would make it feasible to evaluate intracranial pressure through sensitive and specific changes in the energy absorbance of the middle ear. It could represent a non-invasive method of monitoring intracranial pressure.

This is a prospective monocentric longitudinal study. All adult patients in intensive care for head trauma, intracranial hypertension, or after cranial surgery and requiring invasive monitoring of ICP will be included after their non-opposition has been collected.

In a group of 10 controls, multifrequency tympanometry will be performed in the standing position, in the 0° supine position and in the Tredelenburg position at -17°.


Eligibility criteria: Inclusion Criteria:

Patients:

* Person who did not oppose to their inclusion in the trial
* Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke...) requiring monitoring of ICP by a subdural or epidural sensor.
* Age \> 18 years old

Controls:

* Person who did not oppose to their inclusion in the trial
* Age \> 18 years old
* No otologic or neurological history.

Exclusion Criteria:

* Person subject to a measure of legal protection (curatorship, guardianship)
* Person under judicial control
* Pregnant, parturient or breastfeeding woman
* Minor
* Fracture of the petrosal bone, abnormality of the bilateral middle or inner ear or canal preventing tympanometry

Primary outcomes:
measure: Volume of the ear canal as a function of intracranial pressure
timeFrame: Approximately on the 10th day
measure: Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure
timeFrame: Approximately on the 10th day
measure: Middle ear resonance frequency as a function of intracranial pressure
timeFrame: Approximately on the 10th day
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: