louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01978470: External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy
Official title: External Trigeminal Nerve Stimulation for Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seizure Disorder
Keywords: epilepsy
drug resistent epilepsy
partial onset seizures
trigeminal nerve stimulation
neuromodulation
Lead sponsor: NeuroSigma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Olive View-UCLA Education & Research Institute
First posted: 2013-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.

Detailed description: This study evaluates the safety and tolerability of the NeuroSigma eTNS system for the treatment of drug resistent partial seizures.

Up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at Olive View/UCLA Medical Center .......

Enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Partial onset seizures (complex partial or secondary generalized tonic-clonic)
* At least one seizure every three months
* No serious or progressive medical or psychiatric illness
* At least one complex partial or generalized tonic-clonic seizure in the last three months
* MRI or EEG consistent with localization-related or partial epilepsy
* Exposure to at least two anti-epileptic drugs at adequate doses
* Concurrent use of at least one anti-epileptic drug at adequate doses
* No change in anti-epileptic drug dose for at least 30 days prior to study enrollment

Exclusion Criteria:

* Vagus nerve stimulation (VNS)
* History of non-epileptic seizures
* Inability to maintain accurate seizure calendars (self or caregiver)
* Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month
* History of facial pain or trigeminal neuralgia
* Pregnancy

Primary outcomes:
measure: Safety of eTNS
timeFrame: Four weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Four weeks
measure: Quality of Life
timeFrame: Four weeks
measure: Systolic Blood Pressure and Heart Rate
timeFrame: Four weeks
measure: Skin Irritation
timeFrame: Four weeks
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View/UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT01817270: Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
Official title: A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chickenpox
Lead sponsor: Changchun Keygen Biological Products Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Institute of Biological Products And Materia Medica
First posted: 2013-03-25
Enrollment: 368
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.


Eligibility criteria: Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is aged ≥ 1 year to ≤ 3 years
* Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤ 37.5℃

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Failed to the Expanded Programme on Immunization(EPI)
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Plan to receive any vaccine in the 4 weeks following the trial vaccination
* Known bleeding disorder
* Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
* Participation in any other interventional clinical trial
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Primary outcomes:
measure: Seroconversion rate and GMTs for live attenuated varicella vaccine
timeFrame: 35-42 days after the first and second doses
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: within 30 days after each vaccination
Other outcomes:
Locations:
city: Yunfu
country: China
facility: Xinxing Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Huizhen Zheng, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06111170: Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation
Official title: Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatochalasis of Eyelid
Lead sponsor: Augenklinik LMU
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms. After randomization one eyelid of each patient was applied with a compression dressing, the other eyelid not.
Primary purpose: TREATMENT

Brief summary: Study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, OSI and discomfort of the patients after blepharoplasty if a compression dressing is used or not.


Eligibility criteria: Inclusion Criteria:

* Patients with upper eyelid dermatochalasis who were scheduled for upper eyelid blepharoplasty

Exclusion Criteria:

* previous surgery on the upper eyelid, previous eye lid trauma, congenital lid changes, blepharochalasis syndrome, coagulation disorders or indication for combined ptosis and blepharoplasty surgery

Primary outcomes:
measure: Edema
timeFrame: Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Augenklink LMU
Study officials:
References:
Clinical trial NCT02936570: Sun Protection Factor Assay (SPF Assay 206/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT06629870: Dental Anxiety During Restorative Dental Treatment
Official title: Evaluation of the Effect of Hypnotherapy, Virtual Reality and Mindfulness Applications on Dental Anxiety During Restorative Dental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnotherapy
Virtual Reality
Mindfulness
Keywords: Dental anxiety, hypnotherapy, virtual reality glasses application, mindfulness-based meditation practice
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety refers to behavioural disorders associated with excessive fear and anxiety. Dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. This may cause patients to avoid dental treatments and may adversely affect oral health.

This study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.


Eligibility criteria: Inclusion Criteria:

* A modified dental anxiety score of 20 and above
* A dental fear scale score of 59 and above
* D2 level caries according to radiographic caries classification system,
* Systemically healthy patients

Exclusion Criteria:

* Balance disorders such as nystagmus and vertigo,
* Pregnant woman
* Claustrophobia
* Physical or mental disability
* Not knowing how to read and write
* Psychological disturbance
* Taking antidepressants or anxiolytics

Primary outcomes:
measure: Modified Dental Anxiety Scale
timeFrame: 5 minutes before procedure and 5 minutes after procedure
Secondary outcomes:
measure: Dental Fear Survey
timeFrame: 5 minutes before procedure and 5 minutes after procedure
measure: The Visual Analogue Scale
timeFrame: 5 minutes after procedure
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Dentistry
state: Yakutiye
Study officials:
References:
citation: Joda T, Gallucci GO, Wismeijer D, Zitzmann NU. Augmented and virtual reality in dental medicine: A systematic review. Comput Biol Med. 2019 May;108:93-100. doi: 10.1016/j.compbiomed.2019.03.012. Epub 2019 Mar 15.
citation: Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
Clinical trial NCT00523770: Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae
Official title: An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Streptococcal
Keywords: Invasive Pneumococcal Diseases
Pneumonia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Belgium and Finland

Brief summary: GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 65 and 85 years of age at the time of the study.
* Written informed consent obtained from the subject
* Healthy subjects as established by medical history and clinical examination before entering into the study

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae in the 3 months before study start,
* History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start

Primary outcomes:
measure: Positive or negative result using Binax NOW S. pneumoniae Test
timeFrame: within one day
Secondary outcomes:
measure: Positive or negative result using the test to be developed for typing of S. pneumoniae
timeFrame: within one day
measure: Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi)
timeFrame: within one day
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06259370: Benefits of VILPA in Young Adults
Official title: Benefits of Wearable Acceleration-Monitored Simulated Vigorous Intermittent Lifestyle Physical Activity (VILPA) in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activity, Motor
Health Behavior
Keywords: vigorous intermittent lifestyle physical activity
wearable device
Isokinetic strength testing
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinicaltrial is to assess and compare isokinetic performance, surface electromyography, laboratory parameters, and cardiorespiratory function both before and after engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy population.

The main question it aims to answer is:

\[1\] Does VILPA yield effective outcomes? Throughout the course of the trial, participants will engage in a simulated regimen of vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of the exercise protocol will be quantified and evaluated through the utilization of a wearable device.


Eligibility criteria: Inclusion Criteria:

* Healthy Adults
* No exercise habits (more than 3 months)

Exclusion Criteria:

* Exercising ≥ 3 times per week;
* the presence of chronic diseases, such as hypertension, hyperglycemic states, etc;
* have conducted an exercise program in the past three months.

Primary outcomes:
measure: Isokinetic strength testing
timeFrame: 30 minutes
measure: Surface electromyography
timeFrame: 15 minutes
Secondary outcomes:
measure: Blood lipid
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Pharmaceutical University
state: Guangdong
Study officials:
affiliation: Department of Health, Guangdong Pharmaceutical University
name: Lizhen Liao, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00456170: Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial
Official title: Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Vaginal Hysterectomy
Keywords: Vaginal
Hysterectomy
Harmonic
Ligasure
Sutures
Modern
Patients undergoing vaginal hysterectomy for various reasons
Lead sponsor: Southern Health
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2007-04-04
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

Detailed description: Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.

After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.

A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.

The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

Eligibility criteria: Inclusion Criteria:

* Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

* No patient consent

Primary outcomes:
measure: Pain score
measure: Time to discharge
measure: Blood loss
Secondary outcomes:
measure: Cost
measure: Complications
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Moorabin Hospital
state: Victoria
Study officials:
affiliation: Southern Health
name: Jason J Tan, MBBS MRANZCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441370: Patient Satisfaction During Physiological Water or Land Birth: a Prospective Study in an French Tertiary Maternity Unit.
Official title: Patient Satisfaction With Physiological Childbirth in Water or on Land a Prospective Study at the Tourcoing Hospital Maternity Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Water Birth
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have chosen to give birth physiologically at the Maternity unit will be offered the study during their maternity stay.

Brief summary: A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water.

The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Social security beneficiary
* Presence of a companion
* Delivery greater than or equal to 37 weeks of amenorhoea
* Spontaneous labor
* Cephalic presentation
* Physiological delivery by woman's choice according to 2017 HAS criteria (French recommendations)

Exclusion Criteria:

* Patient under court protection
* Patient under guardianship or curatorship
* Placement of an epidural
* Language barrier
* Unexpected delivery (unwanted by the woman)
* Scarred uterus
* Meconium fluid
* Maternal pathologies: epilepsy, MS (depending on neurological opinion), diabetes (types 1 and 2), herpes infection, HIV, HBV, HCV
* History of delivery hemorrhage \> 1L
* History of shoulder dystocia/clavicle fracture
* Metrorrhagia
* Administration of nalbuphine within 2 hours of birth.

Primary outcomes:
measure: Perceived control over childbirth
timeFrame: This questionnaire will be achieved by participating women within 3 days postpartum, before discharge from the maternity ward.
Secondary outcomes:
measure: Dimension of the quality and experience of childbirth within 3 days of delivery
timeFrame: This questionnaire is to be completed within 3 days of delivery, before discharge from the maternity hospital.
measure: Dimension of the quality and experience of childbirth within 2 months of delivery
timeFrame: This questionnaire is to be completed within 2 months of delivery.
measure: Anxiety and depression at 2 months of delivery.
timeFrame: This questionnaire is to be completed within 2 months of delivery.
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: Tourcoing Hospital
state: Hauts De France
Study officials:
affiliation: Tourcoing Hospital
name: GOBERT JG julia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tourcoing Hospital
name: GAILLARD JG Julie
role: PRINCIPAL_INVESTIGATOR
References: