louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06724718: Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
Official title: Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Atrial Fibrillation
Thoracic Surgery
Smartwatches
Rhythm Monitoring
Cardiovascular Prognosis
Asymptomatic Atrial Fibrillation
Randomized Trial
Keywords: Postoperative atrial fibrillation
thoracic surgery
smartwatches
rhythm monitoring
cardiovascular prognosis
asymptomatic atrial fibrillation
randomized trial
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Clinique Victor Pauchet
First posted: 2024-12-09
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.


Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years old).
* Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
* Scheduled pneumonectomy or lobectomy.
* Admission to a conventional surgical unit postoperatively.
* Ability to perform single-lead ECG using a smartwatch.
* Coverage under a social security system.
* Signed informed consent

Exclusion Criteria:

* History of atrial fibrillation.
* Requirement for telemetry for AV block or tachyarrhythmias (\>140 bpm).
* Dependency on a pacemaker.
* Participation in another interventional clinical trial affecting POAF incidence.
* Mediastinal, pleural, or chest wall surgery.
* Reoperations or surgeries performed more than 48 hours prior.
* Pregnant women.
* Patients under guardians or similar legal protection.

Primary outcomes:
measure: the incidence of POAF
timeFrame: at day 7
Secondary outcomes:
measure: Rate of asymptomatic POAF
timeFrame: at day 7
measure: Cardiovascular prognosis
timeFrame: at day 3
measure: Cardiovascular prognosis
timeFrame: at 6 months
measure: Feasibility of rhythm monitoring with a smartwatch
timeFrame: at day 7
measure: Recurrence of AF
timeFrame: at 3 months
measure: Recurrence of AF
timeFrame: at 6 months
measure: management of AF
timeFrame: at 3 months
measure: management of AF
timeFrame: at 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre hospitalier Amiens
Study officials:
affiliation: Centre Hospitalier Amiens
name: Pierre Huette, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00779818: Electrical Acupuncture and Laser Therapy for Low Back Pain
Official title: Electrical Acupuncture and Laser Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Low Back Pain
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.

Detailed description: The purpose of the study is to investigate the effects of electroacupuncture and laser therapy to treat chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* Low back pain for over 6 weeks

Exclusion Criteria:

* Individuals with cancer
* Tuberculosis
* Pacemakers
* Pregnancy
* Osteoporosis
* Heart disease
* Kidney failure
* Thyroid disorders
* Diabetes
* Chronic disease
* Neurological diseases
* Skin or bleeding disorders
* Currently taking drugs or medications
* A health history questionnaire will be used to screen subjects

Primary outcomes:
measure: Measure: Low Back Pain Disability Index, VAS Questionnaire, Revised Oswestry Pain Questionnaire
timeFrame: Before treatment and every two weeks for six weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT04594018: Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
Official title: National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Androgenetic Alopecia
Keywords: androgenetic alopecia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 190
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;
* Participants with a history of surgical treatment for hair loss or shaved scalp;
* Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;
* Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;
* Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;
* Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;
* Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;
* Participants with diseases that can affect hair growth;
* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;

Primary outcomes:
measure: Change from baseline in hair density.
timeFrame: 6 months
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto Da Pele
state: São Paulo
Study officials:
References:
Clinical trial NCT04693013: Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Official title: Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineum; Injury
Episiotomy Wound
Anxiety
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-05
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations

Detailed description: Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman.

The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level.

84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS.

Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.

Eligibility criteria: Inclusion Criteria:

* Post-partum vaginal delivery, spontaneous or instrumental
* Episiotomy or 1st or 2nd degree perineal tear
* informed consent

Exclusion Criteria:

* Cesarean delivery
* 3rd or 4th degree perineal tear
* no informed consent

Primary outcomes:
measure: Anxiety Level
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Pain Level
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Safed
country: Israel
facility: David Peleg
Study officials:
References:
Clinical trial NCT04148313: A Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Sclerosis
MS
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors of any age diagnosed with Multiple Sclerosis

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Multiple Sclerosis.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Multiple Sclerosis.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).

Diagnosis of Multiple Sclerosis.

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01623713: Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Iloperidone
Efficacy
Keywords: schizophrenia
iloperidone
Risperidone
Efficacy
Safety
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 260
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: The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Men or women ages 18-65 years old.
* DSM-IV diagnosis of schizophrenia.
* PANSS≥70.
* Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
* Written informed consent.

Exclusion Criteria:

* Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
* Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.

Primary outcomes:
measure: Positive and Negative Symptom Scale(PANSS)-Total Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Effective percentage(PANSS score reduce rate≥50%)
timeFrame: 6 weeks
measure: Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)
timeFrame: 6 weeks
measure: Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)
timeFrame: 6 weeks
measure: Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Peking
country: China
facility: Sixth Hospital of Peking University
state: Beijing
Study officials:
References:
citation: Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.
Clinical trial NCT00912613: Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness
Official title: ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Critical illness
ICU Diaries
Post Traumatic Stress Disorder
Incidence
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: St Helens & Knowsley Teaching Hospitals NHS Trust
name: Vrinnevishuset, Sweden
name: Università degli Studi di Ferrara
name: University of Copenhagen
name: Haukeland University Hospital
name: Hospital Pedro Hispano
name: Sahlgrenska University Hospital
name: General Hospital of Santo António
First posted: 2009-06-03
Enrollment: 352
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 incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.


Eligibility criteria: Inclusion Criteria:

* Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)

Exclusion Criteria:

* ICU stay \< 72 hours
* Too confused for informed consent
* Pre-existing psychotic illness

Primary outcomes:
measure: Diagnosis of Post Traumatic Stress Disorder
timeFrame: 3 months post critical illness
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Liverpool
name: Richard D Griffiths, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
Clinical trial NCT00663013: Virtual Reality for Burn Wound Care Pain Control
Official title: Virtual Reality for Burn Wound Care Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Anxiety
Keywords: burn
pain
anxiety
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators propose to study the effects of virtual reality (VR) on patients' pain perception during burn wound care. Such variables include psychiatric diagnosis and standard pain coping (i.e. pain catastophizer vs. non-pain catastrophizer).Aims: The investigators intend to evaluate the use of virtual reality in pain distraction for burn patients undergoing burn wound care. To that end our aims are: 1) To determine if pain perception will be less during the portion of the procedure in which the patient is immersed in the VR session in comparison to the portion of wound care which will occur without VR immersion. 2) To determine if anticipatory anxiety will be less for the portion of wound care that includes the virtual reality in comparison to the portion without virtual reality. 3) To determine if current psychiatric diagnosis, especially acute stress disorder and depression, is related to higher pain perception and greater decrease in pain with the virtual reality distraction. 4) To determine if being a "pain catastrophizer" is related to higher pain perception and greater benefits from the


Eligibility criteria: Inclusion Criteria:

* Age 12-100years
* Minimum burn wound size of 2% total body surface area (TBSA) excluding head and dominant hand
* Be able to sit upright independently in bed
* Minimum pain rating of 4/10 on a Visual Analog Scale (only using the most painful extremity).
* Able to consent to the study

Exclusion Criteria:

* Known history of motion sickness
* Seizures
* Migraines
* Current psychosis, dementia, or delirium
* Current blindness and/or deafness that significantly affects their ability to experience the VR

Primary outcomes:
measure: pain perception
timeFrame: immediate
measure: anticipatory anxiety
timeFrame: immediate
measure: current psychiatric diagnosis, is related to pain
timeFrame: immediate
measure: "pain catastrophizing" is related to higher pain perception and greater benefits from the VR
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital, WRH Burn Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Roger W Yurt, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04014218: Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course
Official title: Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ARDS
Keywords: sedation
ARDS
sepsis
outcome
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
Collaborators: name: I.M. Sechenov First Moscow State Medical University
First posted: 2019-07-10
Enrollment: 80
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: Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.


Eligibility criteria: Inclusion Criteria:

* sepsis
* ARDS
* P/F Ratio 100-250
* start of mechanical ventilation

Exclusion Criteria:

* pregnancy
* concomitant oncological disease
* prior psychological impairment

Primary outcomes:
measure: mortality
timeFrame: 28 days after ICU admission
measure: ICU Length of stay (LOS)
timeFrame: 45 days after ICU admission
measure: Length of mechanical ventilation (LMV)
timeFrame: 45 days after ICU admission
Secondary outcomes:
measure: P/F Ratio
timeFrame: 45 days after ICU admission
measure: Delirium
timeFrame: 5 days after ICU admission
measure: MACCE
timeFrame: 28 days after ICU admission
measure: event of RRT
timeFrame: 28 days after ICU admission
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Study officials:
affiliation: Moscow Regional Clinical and Research Institute, Department of Intensive Care
name: Valery V Likhvantsev,
role: PRINCIPAL_INVESTIGATOR
References: