louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04687644: Woman Centred Childbirth Care Training
Official title: The Effect of Woman Centred Childbirth Care Training on Midwives' Patient Centred Care Competency and Job Satisfaction Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Problems
Keywords: woman centred care
patient centred care competency
job satisfaction
online education
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online Education Program
Primary purpose: OTHER

Brief summary: Woman centred childbirth care has become more meaningful and important in today's conditions. Although women-centred childbirth care is frequently mentioned in the literature, it is thought that there are no studies on this subject and it will be beneficial to train midwives on this subject. In this study, it is aimed to examine the effect of online education that will be given to midwives based on the Midwifery Model of Women-Centred Childbirth Care, on both patient-centred care competency and job satisfaction levels.

Detailed description: Research type: Semi-experimental research -Pre-test with control group, post-test designed- Population and sample selection: The universe of the study consists of all midwives who work in the childbirth unite. The effect rate of the intervention in the research, for which the studies on the job satisfaction level of midwives are descriptive in the literature, is unknown. Therefore, Cohen standard effect rate was used. According to the sample size analysis performed in the G-Power program for the sampling, a total of 48 volunteers will be included in the study, with the power of the research being 80%, the alpha of 0.05 and the Cohen standard effect ratio of 0.8, as 26 for the intervention group and 26 for the control group. It is planned to include 52 midwives.

Hypotheses

1. Hypothesis: H0: There is no difference in patient-centered care competence levels between midwives who attended the Women-Centred Midwifery Care Training Program and those who did not.

H1: The patient-centered care competence level of midwives participating in the Women-Centred Midwifery Care Training Program is higher than the control group.

Hypothesis 2:

H0: There is no difference in job satisfaction between midwives who attended the Women-Centred Midwifery Care Training Program and those who did not.

H1: Job satisfaction of midwives participating in the Women-Centred Midwifery Care Training Program is higher than the control group.

Eligibility criteria: Inclusion Criteria:

* Being midwife
* Working in a childbirth unit

Exclusion Criteria:

* Midwives having a Coronavirus Disease-19 (COVID-19) infection

Primary outcomes:
measure: Patient Centred Care Competency
timeFrame: 2 months
measure: Job Satisfaction
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir University
Study officials:
References:
Clinical trial NCT02693444: Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
Official title: Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff
Subacromial Impingement Syndrome
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 0
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: Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy.

The purpose of this study is to further understand the effect pain has by measuring constant shoulder scores in patients before and after ultrasound guided subacromial (the outer end of the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The saline and lidocaine has been approved for use by the U.S. Food and Drug Administration (FDA). The constant shoulder score includes your level of pain, activity level, range of motion and strength measures.


Eligibility criteria: Inclusion Criteria:

* Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair
* Written informed consent is obtained

Exclusion Criteria:

* Revision Surgery
* Irreparable tear or partial tear
* Subscapularis involvement
* Any patient lacking decisional capability

Primary outcomes:
measure: Constant Shoulder Score
timeFrame: 10 minutes following injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Brian Forsythe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forsythe B, Agarwalla A, Puzzitiello RN, Patel BH, Lu Y, Verma NN, Romeo AA, Cole BJ. Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial. Orthop J Sports Med. 2020 Jan 3;8(1):2325967119892331. doi: 10.1177/2325967119892331. eCollection 2020 Jan.
Clinical trial NCT05400044: Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
Official title: Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophic Maxilla
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of bone quality and quantity for three dimensional bone augmentation for maxilla using titanium meshes loaded with bone marrow aspirate mixed with xenograft versus xenograft mixed with autografts only


Eligibility criteria: Inclusion Criteria:

* Patients are free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.

  * Edentulous anterior or posterior maxilla with deficient alveolar ridge that is less than 5 mm measured from the crest of the alveolar ridge to the nasal or maxillary sinus and less than 4mm in buccolingual width.
  * The minimum number of missing teeth in the alveolar ridge is two adjacent teeth.

Exclusion Criteria:

* Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.

  * Previous grafting procedures in the edentulous area.

Primary outcomes:
measure: Histomorphometric bone analysis
timeFrame: 4 months
Secondary outcomes:
measure: Alveolar ridge vertical bone and horizontal bone gain
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT06628544: Trained Immunity in Fungal Infection and Its Mechanism
Official title: The Role of Trained Immunity in Fungal Infection and the Mechanism Behind it
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: BCG Vaccination
Keywords: immunity
metformin
BCG
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Vaccines (BCG) and Drugs (Metformin)
Primary purpose: BASIC_SCIENCE

Brief summary: Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on day 6). On the day 0 (total 20; n = 10 for BCG vaccination, n = 10 for BCG vaccination plus taking metformin), day 14 (total 30; n=15 for BCG vaccination, n = 15 for BCG vaccination plus taking metformin), day 90 (total 26; n = 13 for BCG vaccination, n=13 for BCG vaccination plus taking metformin) of BCG vaccination, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Healthy BCG-naive participants.
* The ages range from 20 to 45.
* Participants without any infections or immune deficiencies.

Exclusion Criteria:

* Participants when infections or other illnesses occurred during the clinical trial.
* Participants who have a fever of unknown causes during the clinical trial.
* Participants who have gotten other vaccines during the clinical trial.

Primary outcomes:
measure: The level of IL-6
timeFrame: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
measure: The level of TGF-alpha
timeFrame: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan University
state: Hubei, China
Study officials:
References:
Clinical trial NCT03083444: P Gingivalis Oral Infection, Intimamedia Thickening in Infants, Atherosclerosis
Official title: Early P Gingivalis Oral Infection and Ultrasound Detection of Intimamedia Thickening in Radial Arteries of Young Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tooth Eruption, Atherosclerosis
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants 4- 24 months of age.

Brief summary: To determine if there is an association between Porphyromonas gingivalis infection of dental gingiva during primary tooth eruption and thickening of the radial artery intimamedial layers. Thickening of these layers in infants could be a promoting factor for later development of atherosclerosis.

Detailed description: Specific Aim 1. To determine the presence of Pg in the mouth of edentulous pre-eruption and then teething infants.

Over a 9-month period 15 normal babies will be recruited for a prospective pilot study from Creighton University students. Cotton swabs of the tongue mucosa and dental plaque will be made to detect the presence of Pg by DNA analysis.

Specific Aim 2. To determine the daily temperature of infants. Daily child temperatures will be recorded by the parent. Specific Aim 3. To measure the thickness of the radial artery using a 50 MHz ultrasound probe.

A 50 MHz ultrasound scan will be made by a trained dental hygienist of the left radial artery at an initial visit and at 3-monthly intervals to measure IMT.

Eligibility criteria: Inclusion Criteria:

* Pre-primary tooth eruption infants in the range of 4-8 months -

Exclusion Criteria:

* No erupted teeth. No diabetes, obesity, chronic inflammatory disorders, hyperlipidemia, -

Primary outcomes:
measure: Arterial wall thickness
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University School of Dentistry
state: Nebraska
Study officials:
affiliation: Creighton University
name: Douglas Benn, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01727544: Vestibular Function Outcome After Cartilage Cap Occlusion Surgery
Official title: Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Vestibular Dizziness
Superior Semicircular Canal Dehiscence
Keywords: superior semicircular canal
non-vestibular dizziness
vestibular dizziness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.

Detailed description: One option for managing a dehiscent superior semicircular canal is surgical intervention. One of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.

Eligibility criteria: Inclusion Criteria:

* ambulatory
* independent self-sufficient adults
* good general health
* medically stable

Exclusion Criteria:

* Medically unstable
* pregnant

Primary outcomes:
measure: objective improvement
timeFrame: baseline to 3 months
Secondary outcomes:
measure: ABC Scale
timeFrame: baseline to 3 months
measure: VAS scores
timeFrame: baseline to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Larry Lundy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00999544: Aprepitant Effects on Oxycodone Response
Official title: New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcotic Abuse
Keywords: opioid
oxycodone
NK1 antagonist
aprepitant
intranasal
abuse
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Merck Sharp & Dohme LLC
First posted: 2009-10-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subject crossover designed that examined 15 experimental conditions within a single group of participants
Primary purpose: BASIC_SCIENCE

Brief summary: Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.

Detailed description: Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.

Eligibility criteria: Inclusion Criteria:

* Recreational user of opioids
* Healthy
* Ages 18-55 years old
* Able to provide informed consent

Exclusion Criteria:

* Ongoing medical or psychiatric condition that would be contraindicated for participation
* Past 30 day use of and P4503A4 inhibitor

Primary outcomes:
measure: Abuse Liability Proxy
timeFrame: 42 days
Secondary outcomes:
measure: Respiration Depression
timeFrame: 42 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Sharon L Walsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.
Clinical trial NCT03252444: Therapeutic Approaches for Subjects With Scapula Dyskinesis
Official title: Therapeutic Approaches for Subjects With Scapula Dyskinesis: Conscious Control, EMG Biofeedback Training, and Intensive Scapula-focused Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement
Keywords: Shoulder dyskinesis
EMG biofeedback training
Intensive Scapula-focused intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.


Eligibility criteria: Inclusion criteria:

* At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
* Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms

Exclusion criteria:

- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy

Primary outcomes:
measure: Shoulder complex kinematics
timeFrame: The scapular kinematics will be measured before scapular control and immediately after scapular control
measure: Shoulder associated muscular activities
timeFrame: The muscle activation will be measured before scapular control and immediately after scapular control
Secondary outcomes:
measure: Forward shoulder posture
timeFrame: After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
measure: Pectoralis minor muscle length
timeFrame: After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jiu- Jenq Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Du WY, Huang TS, Chiu YC, Mao SJ, Hung LW, Liu MF, Yang JL, Lin JJ. Single-Session Video and Electromyography Feedback in Overhead Athletes With Scapular Dyskinesis and Impingement Syndrome. J Athl Train. 2020 Mar;55(3):265-273. doi: 10.4085/1062-6050-490-18. Epub 2019 Dec 26.
Clinical trial NCT05554744: EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors
Official title: Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Endocrine Neoplasia Type 1
Pancreatic Neuroendocrine Tumor
Keywords: Multiple endocrine neoplasia type 1
Pancreatic neuroendocrine tumor
Endoscopic ultrasonography-guided fine-needle injection
Ablation
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs

Detailed description: The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related pNETs.

Eligibility criteria: Inclusion Criteria:

1. Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
2. Patients who refuse surgery.
3. Patients who have given their fully informed consent.

Exclusion Criteria:

1. Patients who are not suitable for the endoscopic procedure.
2. Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.

Primary outcomes:
measure: Changes of blood glucose level
timeFrame: Within 7 days of the last ablation and every 6 months up to 24 months
measure: Changes of insulin level
timeFrame: Within 7 days of the last ablation and every 6 months up to 24 months
measure: Changes of C peptide
timeFrame: Within 7 days of the last ablation and every 6 months up to 24 months
measure: Imaging response
timeFrame: Every 6 months up to 24 months
Secondary outcomes:
measure: Feasibility of EUS-FNI
timeFrame: At the time of procedure
measure: Safety of EUS-FNI
timeFrame: Within 1 month after treatment
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Shanyu Qin, Ph.D
role: STUDY_CHAIR
References: