louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03807544: Treatment Parameters for the Empower Neuromodulation System (ENS)
Official title: Study to Optimize and Validate the Treatment Parameters for the Empower Neuromodulation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: AUD
TENS
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. A clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. The subject will self-administer two treatment sessions at two active treatment sites.


Eligibility criteria: Inclusion Criteria:

1. Is 21-75 years old
2. Can provide informed consent
3. Currently has a stable living situation
4. Had one heavy drinking week (\>7 drinks/week for women; \>14 drinks/week for men) over the past 6 months
5. Has a breath alcohol concentration of 0.00% at enrollment
6. Is willing to follow all study procedures

Exclusion Criteria:

1. Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage
2. Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
3. Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps
4. Is currently pregnant or breastfeeding
5. Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
6. Has used an investigational drug/device therapy within the past 4 weeks
7. Is deemed unsuitable for enrollment in study by the PI

Primary outcomes:
measure: Number of Participants Who Experienced Effective Electrode Placement
timeFrame: 2 hours, length of study visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: TheraNova
state: California
Study officials:
References:
Clinical trial NCT01311544: Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients
Official title: Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 92
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 with acute ischemic stroke

Brief summary: The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years
* Eligibility for intravenous thrombolytic treatment (National Institute of Neurological Disorders and Stroke criteria)
* Permanent ischemic stroke confirm with encephalic MRI (Magnetic Resonance Imaging)
* Patient able of accepting protocol information
* Patient who received information about the protocol and had not expressed its opposition to participate

Exclusion Criteria:

* Pacemaker
* Surgical ferromagnetic clips
* Cochlear implants
* Intraocular metallic foreign body
* Iron implants or objects likely to concentrate the Radio Frequency field
* Claustrophobia
* Known intolerance to contrast media (DOTAREM)
* Pregnant women (Beta Human Chorionic gonadotrophin performed for biological assessment of thrombolysis)
* Patient with severe kidney with Glomerular Filtration rate \< 30 ml/min
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Primary outcomes:
measure: Images quality for each cervical and intracranial arteries
timeFrame: 6 months
Secondary outcomes:
measure: Quantification of carotid stenosis with NASCET classification
timeFrame: 6 months
measure: Study of dynamic vascular consequences of carotid stenosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
affiliation: Rennes University Hospital
name: jean-yves gauvrit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02150044: Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2014-05-29
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria:

* History of sensitivity or reaction to anesthesia chosen for the procedure
* Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
* Otitis externa
* Active acute otitis media
* Otitis media pathology requiring T-tubes
* Stenosed ear canal
* Anatomy that precludes sufficient visualization of and access to the tympanic membrane
* Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Primary outcomes:
measure: Ear Outcome Success
timeFrame: Day 0 (at procedure visit)
Secondary outcomes:
measure: Procedure Success
timeFrame: Day 0 (at procedure visit)
measure: Tube Retention
timeFrame: 1 week
Other outcomes:
Locations:
city: Kirkland
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT02412644: Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Official title: Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2015-04-09
Enrollment: 29
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: 12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy

Detailed description: Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.

Eligibility criteria: Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Moderate to severe plaque type psoriasis as defined at baseline by:

   * PASI score of 12 or greater,
   * PGA score of 3 or greater
   * BSA affected by plaque-type psoriasis of 10% or greater,
4. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. Subjects with previous exposure to apremilast
3. Malignancy or history of malignancy, except for:

   * treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas;
   * treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years.

Primary outcomes:
measure: Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36
timeFrame: 36weeks
Secondary outcomes:
measure: Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12
timeFrame: 12WEEKS
measure: Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36
timeFrame: 36 weeks
measure: Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36
timeFrame: 36 weeks
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
affiliation: Psoriasis Treatment Center of Central New Jersey
name: Jerry Bagel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06953544: The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level
Official title: The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Attachment
Childbirth Preparation Program
Antenatal Education
Paternal Behavior
Keywords: Childbirth Preparation Program
Paternal attachment
Antenatal attachment
Midwifery
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 99
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomised controlled trial to examine the effects of a "Father-Sensitive Childbirth Preparation Class" on the level of prenatal attachment. The main question it aims to answer is:

1- How does a father-sensitive birth preparation class affect fathers' prenatal attachment levels?

It was conducted between February 1, 2024, and October 1, 2024, with expectant fathers living in Mersin province, whose spouses were experiencing their first pregnancy, who were between 20-32 weeks' gestation, and who were going to become fathers for the first time.

A total of 99 expectant fathers were included in the study - 50 in the intervention group and 49 in the control group. The intervention group was given a "Father-Sensitive Childbirth Preparation Training" consisting of four sessions, while the control group received a standard "Childbirth Preparation Training", also consisting of four sessions.

The "Descriptive Data Collection Tool" and the "Prenatal Father Attachment Scale" were used to collect the research data.


Eligibility criteria: Inclusion Criteria:

Participants were:

* Over 19 years of age,
* At least literate,
* Whose spouse was between 20 and 32 weeks pregnant,
* Whose spouse was primigravida,
* Whose spouse had a singleton pregnancy,
* With no prior experience of pregnancy, childbirth, or parenting,
* With no history of miscarriage, curettage, or perinatal loss,
* Whose spouse had no pregnancy-related complications or risk factors,
* Who had not previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

Exclusion Criteria:

Participants were excluded if they:

* Had a spouse whose pregnancy was outside the 20-32 week gestation range,
* Had a spouse with a multiple pregnancy,
* Had any pregnancy-related complications or risk factors (high risk),
* Had prior experience of pregnancy, birth, or parenting,
* Had experienced miscarriage, curettage, or perinatal loss,
* Had previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

Primary outcomes:
measure: Paternal Antenatal Attachment Scale (PAAS) total score mean
timeFrame: 14 days after completing the 12-hour father-sensitive childbirth preparation class
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
References:
Clinical trial NCT03004144: Impact of Assistive Forces on Activities of Daily Living
Official title: Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a cross-sectional study investigating the impact of assistive forces applied by the body-weight support system "the FLOAT" on the study participants. The study is conducted at the University Hospital Balgrist in Zurich over a period of around 3 years. During this time measurements on approximately 140 able bodied subjects and 60 patients with an incomplete spinal cord injury will take place. The study participants are invited for a single visit of around 140 min duration to the University Hospital Balgrist. During this visit the study participants will repeatedly perform various activities of daily living (free walking, standing up and sitting down, stair climbing and balancing) with and without assistive forces from the body-weight support system. While performing the tasks, the study participants' motions and muscle activities will be measured to evaluate the naturalness of their movements. In addition, the collected data permits us to compare different movement patterns and make conclusions about effective and optimal movement support. Obtaining this knowledge will help us to shape the therapy of these activities to be tailored to the patients and to train these movements with the help of the FLOAT under optimal conditions.


Eligibility criteria: Inclusion Criteria:

* Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
* informed consent as documented by signature
* bodyweight \< 120 kg

Exclusion Criteria:

* a significant psychiatric or orthopedic diagnose
* any secondary neurological complications that may impact the outcome variables
* dermatological conditions (pressure ulcers, etc.)
* pacemaker or other implanted, electronic devices
* contraindications for FLOAT training
* inability or unwillingness to provide written informed consent or follow study procedures e.g. due to language problems
* psychological disorders, dementia, etc.
* known or suspected non-compliance, drug or alcohol abuse
* enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: 3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks
timeFrame: Once (single visit) around 140 minutes duration
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
References:
Clinical trial NCT06758544: A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination with Chemotherapy for Resectable Pancreatic Cancer
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination with Chemotherapy for Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Resectable pancreatic cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Virotech Pharmaceutical Co., Ltd.
First posted: 2025-01-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

Detailed description: This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

The study is planned to enroll 18 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

Eligibility criteria: Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
2. Males and females at 18-75 years of age, inclusive, at the Screening Visit.
3. Have a clinical diagnosis of pancreatic cancer.
4. An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Expected survival time of≥6 months.
6. No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria:

1. Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
2. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
3. Immunocompromised patients.
4. Known alcohol or drug dependency.
5. Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Safety and tolerability
timeFrame: About 3 years
Secondary outcomes:
measure: Disease-free survival rate
timeFrame: About 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00341744: Providing Access to the Visual Environment
Official title: Providing Access to the Visual Environment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vision Impairment
Keywords: Vision
Aids
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Tennessee Department of Education
First posted: 2006-06-21
Enrollment: 795
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children age 3 to 21 years of age, enrolled in a TN school, with visual impairment

Brief summary: Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices.

Detailed description: Subjects are enrolled each school year based on referrals from school systems in Tennessee, ophthalmologists, and optometrists. A total of 90 new students are enrolled each year. Students are provided a comprehensive low vision rehabilitation evaluation by a low vision optometrist and prescribed optical devices to improve distance appreciation, near reading, and other tasks based on individual needs. Students are then trained to use the devices efficiently by master's level teachers of the visually impaired. The teachers travel to the students environment (school/home/work) for the training.

Variables such as ocular disease, age, visual acuity, visual improvement with optical devices, type of optical device, and reading speed are defined for each student. Providing Access to the Visual Environment also provides...

Eligibility criteria: Inclusion Criteria:

Children age 3 to 21 years of age Enrollment in a school in Tennessee (private or public)

- Children that are eligible for services due to visual impairment Low vision

Exclusion Criteria:

* Children who do not have the potential to become readers or use their vision for reading

Primary outcomes:
measure: Success to utilize optical devices
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Saige Wilkins
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Lori Ann Kehler, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887144: Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
Official title: Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Detailed description: Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the products themselves
4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
5. Have had their ileostomy for at least 3 months
6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
7. Currently using midi or maxi bags
8. Willing to use minimum 1 product every second day (max. 2 days wear time)
9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
10. Must be able to cut products themselves

Exclusion Criteria:

1. Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
6. Known hypersensitivity of the product components and/or ingredients

Primary outcomes:
measure: Degree of leakage
timeFrame: patients will test the products for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
References: