louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04341597: Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)
Official title: Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Transperineal
Keywords: endovaginal
ultrasound
transperineal
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endovaginal ultrasound is currently the gold standard to diagnose a shorted cervical length and, by extension, assess the risk of preterm labor. The major inconvenient is that this is an invasive method of diagnosis that tends to be poorly accepted by some patients. This study aims to evaluate the accuracy of a noninvasive transperineal ultrasound cervical measurement in comparison to the endovaginal technic in 2nd and 3nd trimester pregnant women where a cervical ultrasound is indicated.

Detailed description: The cervical length is a crucial part of the diagnostic of premature labor. The gold standard technic is the endovaginal ultrasound. This is a technic with good reproducibility and good precision. Some authors have found the transperineal technic to present the same characteristics, without being as invasive. The aim of the study was to compare the results of the less invasive technic to the current invasive gold standard in pregnant women who consult for contraction, or for whom cervical modification is suspected in order to determine whether the former could replace the latter.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 2nd and 3rd trimester consulting in obstetric emergency for whom a cervical ultrasound is indicated

Exclusion Criteria:

* minor patients
* mentally deficient persons

Primary outcomes:
measure: difference of measurement of the uterine cervix
timeFrame: at day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03335397: M-learning to Improve Professional Competencies in Health Sciences
Official title: Interactive Learning Strategies Using M-learning for Improving Professional Competencies in Health Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: education
health science
app
m-learning
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 100
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 aim of this study is to investigate whether a mobile application is useful for improving knowledge about professional competencies in students enrolled in Health Sciences degrees.

Detailed description: The learning environment in Higher Education as well as autonomous work of students, mobile technology is increasingly present due to the mass use of mobile devices and the development of high speed in data transmission, which provides today the possibility of being able to access in real time a great amount of information.

M-learning is defined as the ability to access educational resources, tools and materials using a mobile device anytime and anywhere.

Considering the advantages of this technology, m-learning can be a real option to the traditional teaching-learning method by encouraging the active participation of students in their own learning process.

Therefore, this educational innovation study aims to evaluate the effectiveness and the use of a mobile application as a complementary learning strategy in interactive format for the acquisition of professional competencies in Health Sciences.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Access last generation mobile phone
* Enroll 1º course Health Sciences degrees
* Basic english knowledge

Exclusion Criteria:

* Prior experience in Fundaments subject (second enrolment or more not allowed)

Primary outcomes:
measure: Multiple-choice questions
timeFrame: Change scores: Baseline, 2-week intervention
Secondary outcomes:
measure: Instructional Materials Motivation Survey
timeFrame: 2-week intervention
measure: Satisfaction survey questionnaire
timeFrame: 2-week intervention
measure: Profile of Mood States
timeFrame: Change scores: Baseline, 2-week intervention
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Health Science Faculty. University of Granada, Granada (Spain)
name: Irene Cantarero-Villanueva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lozano-Lozano M, Fernandez-Lao C, Cantarero-Villanueva I, Noguerol I, Alvarez-Salvago F, Cruz-Fernandez M, Arroyo-Morales M, Galiano-Castillo N. A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial. J Med Internet Res. 2020 May 22;22(5):e17101. doi: 10.2196/17101.
Clinical trial NCT04882397: Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain
Official title: Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Pain and Joint Position Sense in Individuals With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Joint Position Sense
Soft Tissue
Mobilization
Neck Pain
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 39
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: Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. As a result of our study, we will investigate the effects of instrument-assisted soft tissue mobilization in a single session on perception of pain and joint position.


Eligibility criteria: Inclusion Criteria:

* • Being diagnosed with chronic neck pain,

  * To be in the age range of 18-65.

Exclusion Criteria:

* • Those taking any analgesic medication

  * Those with acute injury or infection,
  * Those with open wounds, Osteoporosis,
  * Broken,
  * Hematoma, Those with acute cardiac, liver and kidney problems,
  * Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
  * Those with circulation problems,
  * Those with peripheral vascular disease, Epilepsy, Surgery history in the cervical area

Primary outcomes:
measure: Change from Baseline Cervical Pain at 2 minutes
timeFrame: Baseline and 2 minutes after intervention
measure: Change from Baseline Joint Position Sense at 2 minutes
timeFrame: Baseline and 2 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
References:
Clinical trial NCT06574997: Expanded Access Program for RP in Adults
Official title: An Expanded Access Program for Retinitis Pigmentosa in Adults Aged 18 Years and Older
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa
Modifier Gene Therapy
Modified Gene Therapy
RHO
RP
NR2E3
Subretinal Injection
Lead sponsor: Ocugen
Sponsor class: INDUSTRY
First posted: 2024-08-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: This intermediate-size patient population expanded access program is to provide access to investigational product OCU400 for up to 75 patients with Retinitis Pigmentosa (RP) outside of the ongoing clinical trial Phase 3 program for patients who do not have access to alternative Food and Drug Administration (FDA)-approved products for treatment of the disease.

Detailed description: This expanded access protocol provides access to OCU400 for a subset of patients. Subjects will undergo specific ocular testing included in the study. Subjects will follow-up with physical examination, review of concomitant medication, blood work and ocular examinations for up to 52 weeks (about 12 months) post dosing.

Eligibility criteria: Inclusion Criteria:

1. Males or females ≥18 years of age at the time of informed consent.
2. Confirmed clinical and CLIA certified genetic diagnosis of RP (except subjects with AD-NR2E3 mutation)
3. Presence of photoreceptors as determined by spectral-domain optical coherence tomography (SD-OCT).

Exclusion Criteria:

1. Subject lacks evidence of outer nuclear layer, i.e., containing the nuclei of the retinal photoreceptors as determined by SD- OCT.
2. Considered unsuitable for any reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, or the Sponsor after reviewing the subject medical history and condition.
3. Previous treatment with a gene-therapy or cell therapy product, excluding OCU400.
4. Previous treatment with any investigational drug or device within one year, excluding OCU400.
5. Any contraindications for subretinal injection.
6. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Deerfield Beach
country: United States
facility: Advanced Research
state: Florida
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: La Crosse
country: United States
facility: Gundersen Health
state: Wisconsin
Study officials:
affiliation: Ocugen
name: Huma Qamar, MD, MPH, CMI
role: STUDY_CHAIR
References:
Clinical trial NCT03926897: Blood Pressure Measuring Practice of Hong Kong Primary Care Doctors
Official title: Blood Pressure Measuring Practice of Hong Kong Primary Care Doctors: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors who regarded themselves working in Primary Care in Hong Kong

Brief summary: Background: While office BP measurements were traditionally used to detect, diagnose and manage hypertension(HT), studies had convincingly showed that out-of-office blood pressure, including home blood pressure monitoring (HBPM) and ambulatory blood pressure monitoring (ABPM), was superior in predicting cardiovascular outcomes and death. Furthermore, some countries' guidelines suggested the use of validated automatic blood pressure machines (called automated office blood pressure monitoring (AOBP)) to screen for HT and record BP in routine HT clinical management. With difference between guidelines and various available BP measurement methods, it is not known how primary care doctors, who play the key role to detect and treat HT, are measuring BP in their daily practice.

Method: All doctors registered in the primary care directory will be mailed a questionnaire. Those who do not respond would be mailing for maximally 3 times, 2 weeks apart to enhance response rate. It is estimated that around 1500-2000 doctors will be eligible.


Eligibility criteria: Inclusion Criteria:

* All doctors registered in the primary care directory in Hong Kong

Exclusion Criteria:

* nil

Primary outcomes:
measure: the blood pressure (BP) measurement method for screening of hypertension
timeFrame: 1 year
measure: The BP measurement method to diagnose hypertension
timeFrame: 1 year
measure: your routine methods used to measure BP in patients taking antihypertensive treatment (lifestyle or medications)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen Clinic
Study officials:
References:
citation: Lee EKP, Choi RCM, Liu L, Gao T, Yip BHK, Wong SYS. Preference of blood pressure measurement methods by primary care doctors in Hong Kong: a cross-sectional survey. BMC Fam Pract. 2020 May 26;21(1):95. doi: 10.1186/s12875-020-01153-6.
Clinical trial NCT06525597: Study of Stapokibart Injection in Patients With Allergic Rhinitis
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.

Detailed description: Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility criteria: Inclusion Criteria:

* Able to understand the study and voluntarily sign the Informed consent form.
* Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
* Subjects with asthma must be evaluated by the researcher as having a stable condition.
* Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).

Exclusion Criteria:

* Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
* Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
* Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period.
* Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
* Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.

Primary outcomes:
measure: Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.
timeFrame: Up to week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, CMU
state: Beijing
Study officials:
affiliation: Beijing Tong-Ren hospital
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06351397: Immersive Mixed Reality Simulation to Evoke Empathy
Official title: Immersive Mixed Reality Simulation to Evoke Empathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum.


Eligibility criteria: Inclusion Criteria:

* Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
* 18 years and older

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea
* have a history of seizures
* are uncomfortable wearing a \~7 pound weighted vest.

Primary outcomes:
measure: Changes in self-reported empathy from before and after the simulation
timeFrame: baseline, immediately after the intervention
Secondary outcomes:
measure: Satisfaction of Design Features of the Simulation
timeFrame: immediately after the intervention
measure: Evaluation of the CHARM system's usability
timeFrame: immediately after simulation
measure: Evaluation of the CHARM system's ergonomics
timeFrame: immediately after simulation
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT03683797: Testing the Efficacy of a Post-discharge Call Program on the Rate of Readmission
Official title: Testing the Efficacy of a Post-discharge Call Program on the Rate of Readmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Transitions
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 3267
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: NYU Langone Health patients receive a call from a clinical care coordinator after they are discharged from the hospital (within 1-3 days). The current study is testing the efficacy of this program.


Eligibility criteria: Inclusion Criteria:

* All patients discharged from NYU Langone Health who are eligible to receive a call from a clinical care coordinator after they were discharged from the hospital.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Rate of readmission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03635697: Mindfulness in Pregnancy
Official title: The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Mindfulness
Keywords: Pregnancy
Mindfulness
Anxiety
Depression
NST
Non-stress test
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English as primary language
* less than 36 weeks gestational age
* at least 28 weeks gestational age

Exclusion Criteria:

* Use of psychoactive medications
* Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
* History of suicide attempt or current suicidal ideations
* Uncontrolled substance abuse in the last 6 months
* Patients with hearing loss
* More than three no-shows to NST appointments

Primary outcomes:
measure: Beck Anxiety Inventory Score
timeFrame: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
measure: Edinburgh Postnatal Depression Scale Score
timeFrame: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health / John Dempsey Hospital
state: Connecticut
Study officials:
affiliation: UConn Health
name: Christopher M Morosky, MD
role: PRINCIPAL_INVESTIGATOR
References: