louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03270618: Accuracy of a CAD/CAM Surgical Template for Mandible Distraction
Official title: Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Asymmetry
Mandible; Hypoplasia, Unilateral Condylar
Distraction of Bone
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.


Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled to undergo mandibular DO via intraoral approach
* Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment
* Patients who agreed to participate in this study

Exclusion Criteria:

* Patients requiring more than one distractor of the mandible
* Patients with mandible defect
* Patients with previous mandibular trauma

Primary outcomes:
measure: Linear differences of the distractor position
timeFrame: within latency period (5-7 days after the surgery)
measure: angular differences of the distractor vector
timeFrame: within latency period (5-7 days after the surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
name: Xudong Wang
role: STUDY_CHAIR
References:
Clinical trial NCT00622518: Ear Drops for Children With Otitis Media
Official title: Ear Drops for Children With Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Otitis Media
Keywords: otitis media
children
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Standard Homeopathic Company
First posted: 2008-02-25
Enrollment: 119
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.


Eligibility criteria: Inclusion Criteria:

* Presenting to participating clinic with otitis media
* Diagnosed with acute otitis media
* Parents rate symptoms as a "moderate problem" or more

Exclusion Criteria:

* Diagnosis of otitis media within preceding 30 days
* Receipt of antibiotics within 2 days
* Perforated ear drum or bullous lesion
* Receipt of homeopathic treatment within 30 days

Primary outcomes:
measure: Resolution of Otitis Media Symptoms
timeFrame: 5 days
Secondary outcomes:
measure: Side Effects of Therapy
timeFrame: 5 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center-Roosevelt Pediatric Care Center
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202318: Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers
Official title: Pilot Prospective Cohort to Determine the Comparative Diagnostic Accuracy of Card 28 to Card 28 and Cincinnati Stroke Scale.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Keywords: Cerebrovascular Accident
Stroke,Acute
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target study population consists of all 911 callers with symptoms suggestive of stroke in the participating county. Specifically, the accessible population for this study is the group of patients whose 911 calls are answered and interrogated by the emergency medical dispatchers at the County Communication Center, Santa Clara.

Brief summary: This study will compare the diagnostic accuracy of Card 28 stroke protocol to Card 28 and Cincinnati Stroke Scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke.

The authors hypothesize that a combination of Card 28 plus the Cincinnati Stroke Scale (CSS) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.


Eligibility criteria: Inclusion Criteria:

1. All 911 calls transferred by local Public Service Answering Points (PSAPs) to the County Communication center of Santa Clara County where the emergency medical dispatchers complete the interrogation using MPDS protocols.
2. All 911 calls received directly at the County Communication center of Santa Clara County where emergency medical dispatchers complete the interrogation using the MPDS protocols.
3. All 911 calls received from subjects (patient) aged \> 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects \> 18 years of age.

Exclusion Criteria:

1. All calls that require immediate response (ECHO level determinant for life threatening conditions) and emergency medical dispatchers cannot complete Card 28
2. Calls answered by emergency medical dispatchers who have not completed training on the use of Cincinnati Stroke Scale.
3. Calls originating from the cities of Palo Alto, Mountain View, Sunnyvale, Santa Clara, and San Jose that are not interrogated by the County Communication Center for Santa Clara County.
4. 911 calls with no available outcomes in the final discharge database.

   -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alameda
country: United States
facility: Alameda County
state: California
Study officials:
affiliation: University of California, San Francisco
name: Prasanthi Govindarajan, MBBS, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125418: Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
Official title: Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Peri-implant Tissue Response With Use of Customized Healing Abutments
Keywords: dental implant, customized healing abutment
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients in each group will received different types of customized healing abutment
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:

• effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.

Detailed description: Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age;
* patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
* sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
* had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.

Exclusion Criteria:

* medical and general contraindications for the surgical procedure;
* heavy smokers (\>10 cigarettes/day);
* an active infection at the implant site.

Primary outcomes:
measure: soft tissue alteration
timeFrame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
measure: hard tissue alteration
timeFrame: T0 baseline before implant placement, 6month follow up, 12month follow up
measure: volumetric alteration
timeFrame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
Secondary outcomes:
measure: pain numerical rating scale
timeFrame: at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery
measure: pink esthetic score
timeFrame: T0 baseline before implant placement, 6 month follow up
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Pimduen Rungsiyakull, AssocProfDr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04250818: Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Official title: Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Metastatic Triple-Negative Breast Cancer
Keywords: cytokine, breast cancer
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with triple negative breast cancer

Brief summary: Recent progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies including breast cancer. It has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. In this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.

Detailed description: This is a prospective study that has two groups of patients as determined by their prescribed treatment plan. Group A (control group) are patients with metastatic triple-negative breast cancer (TNBC) who receive chemotherapy only (current standard of care). Group B (experimental group) are patients with mTNBC who receive a combination of chemotherapy and IT immunotherapy (Atezolizumab) which is a standard of care for patients whose tumor express \>1% of PD-L1 molecules. T-cell cytokines will be measures prior to treatment and at multiple time points during the treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic triple negative breast cancer
* 18 years of age or older

Exclusion Criteria:

* Younger than 18
* Unwilling to participate or unable to give informed consent

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University HSC El Paso
state: Texas
Study officials:
References:
Clinical trial NCT00652418: Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
Official title: Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Magnetic Resonance Angiography
Peripheral Vascular Diseases
Peripheral Arterial Diseases
Keywords: Magnevist
Magnetic Resonance Angiography
Meglumine gadopentetate
Determination of effective dose in MRA
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

Exclusion Criteria:

* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
* Patients with allergy to contrast media
* Patients with serious hepatic impairment
* Patients with serious renal impairment

Primary outcomes:
measure: Diagnostic ability
timeFrame: MRI image in blinded read
Secondary outcomes:
measure: Visibility
timeFrame: MRI image in blinded read
measure: Diagnostic confidence
timeFrame: MRI image in blinded read
Other outcomes:
Locations:
city: Hirosaki-shi
country: Japan
state: Aomori
city: Funai-gun
country: Japan
state: Kyoto
city: Hamamatsu-shi
country: Japan
state: Shizuoka
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06352918: Peripheral Central Catheter (PICC) Care
Official title: The Effect of Palmar Grasp Reflex Stimulation on Pain and Comfort Level in Peripherally Inducted Central Catheter (PICC) Care in Preterm Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NEWBORN
Pain, Acute
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.

Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies.


Eligibility criteria: Inclusion Criteria:

* Without congenital defects,
* Not receiving sedation at least 3 hours before PICC care,
* No unexplained crying,
* Without neurological problems,
* Not undergoing surgical intervention,
* Babies with PICC insertion

Exclusion Criteria:

* Having had a painful procedure (invasive procedure, etc.) within the last hour,
* Babies for whom permission was not obtained from the parent through an informed voluntary consent form

Primary outcomes:
measure: Pain level
timeFrame: 8 months
Secondary outcomes:
measure: Comfort
timeFrame: 8 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT00129818: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Official title: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genital Herpes
Keywords: Genital herpes
viral shedding
famciclovir
Symptomatic genital herpes
Asymptomatic genital herpes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes

Exclusion Criteria:

* Pregnancy
* History of renal dysfunction
* Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
* Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure

Primary outcomes:
measure: Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
measure: Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions
Secondary outcomes:
measure: reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
measure: quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
measure: time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
measure: oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
measure: reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Indianapolis
country: United States
facility: IU Center for Clinical STD Research
state: Indiana
city: Raleigh
country: United States
facility: UNC Clinical Research - Raleigh
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynne Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Seattle
country: United States
facility: University of Washington - Virology Research Clinic
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT04092218: Prevalence of Parenting Style and Child Behavior
Official title: Prevalence of Parenting Style in Group of Children With Primary Dentition in Their First Dental Visit- A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Behavior
Parenting
Parent-Child Relations
Keywords: parenting style
child behavior
first dental visit
caries experience
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with primary dentition during their first dental visit and their parents or caregiver

Brief summary: Prevalence of parenting style and assessment of child behavior and caries experience in relation to parenting style during first dental visit.

Detailed description: The success of dental visit depends on the child's behavior and cooperation which can be recognized from the child's first visit. Child's behavior can be affected by the parenting style. There are four types of parenting styles: authoritative, authoritarian, permissive and neglecting, each affects the child in different ways.

Recently parenting styles became very interesting since parents are the primary caregivers and they have a great impact on the child's psychological and emotional development.

However, every parent seeks for a rapid and easy treatment for their children, but if the child is uncooperative that will require multiple dental visits , more expenses or he/she might undergo general anesthesia which is more expensive.

Also, the parent-child relationship is very important ,bad relationship can cause insecurities, lack of self confidence and trust, resulting in the future a fearful and irresponsible man / woman.

Eligibility criteria: Inclusion Criteria:

* children with Primary teeth
* Before the eruption of permanent molar
* First dental visit
* Both genders

Exclusion Criteria:

* Children with systemic diseases or congenital problems
* Parents refuse to participate

Primary outcomes:
measure: Parenting style
timeFrame: 1 year
Secondary outcomes:
measure: Behavior of children
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Howenstein J, Kumar A, Casamassimo PS, McTigue D, Coury D, Yin H. Correlating parenting styles with child behavior and caries. Pediatr Dent. 2015 Jan-Feb;37(1):59-64.
citation: Park H, Walton-Moss B. Parenting style, parenting stress, and children's health-related behaviors. J Dev Behav Pediatr. 2012 Jul;33(6):495-503. doi: 10.1097/DBP.0b013e318258bdb8.
citation: Aminabadi NA, Farahani RM. Correlation of parenting style and pediatric behavior guidance strategies in the dental setting: preliminary findings. Acta Odontol Scand. 2008 Apr;66(2):99-104. doi: 10.1080/00016350802001322.